Total 3 Senior Executive manufacturing job vacancies in Malaysia

Job Description

Position Description:

Senior Manufacturing Automation Engineer - Hybrid

The Senior Manufacturing Automation Engineer is responsible for day-to-day operations support activities for process control systems in a vaccine manufacturing facility. the Senior engineer will be the lead engineer of a small team of 2-3 engineers providing day-to-day coordination of tasks, serving as the first point of escalation for the area, and acting as the primary automation change control approver.

The automation technologies may include but are not limited to the following technologies:  Distributed Control Systems (Delta V), Programmable Logic Controllers (Allen Bradley), OEM systems to include Washers, Autoclaves, Filter Integrity Testers, and purified water systems (WFI/Clean Steam). 

Key Functions

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Understand and support all GMPs, safety, and environmental regulations

• System upgrades, troubleshooting issues, identifying trends, process monitoring, system administration, documentation updates, data querying, operator training and participating in deviation investigations

• Ensure automation documents, preventive maintenance, periodic reviews, and SOPs are in an inspection-ready state

• Support process automation inquiries during internal and external audits/inspections and must, therefore, be able to speak knowledgeably about automation, process and cGMP details of the manufacturing operations

• Evaluate automated and information technology systems and develop strategies to optimize and ensure the quality and stability of automation systems through future expansion, replacement, or upgrade

• Use their technical knowledge to assure the efficient operation of a variety of automated processing and information technology systems

• Lead in installation and qualification of new equipment into operations

• Develop solutions for automation problems

• Participate and contribute to investigations of automation anomalies to prevent a recurrence, which includes on-the-floor support of manufacturing activities

• Lead in the development of technical requirements, keeping in mind the associated technology needs, benefits, and risks

• Analyze complex business requirements using tools and techniques and identifies internal/external solutions to meet these requirements

• Lead in developing control strategies and applying computerized tools that will deliver tangible improvements to overall production unit performance

• Communicate daily with the business, technical, and quality representatives within the area of support through the tier process

• Provide off-site weekend/evening automation phone or on-site support on a rotational basis

• Familiar with lean manufacturing principles with an ability to convert business logic and requirements into detailed system requirements

Position Qualifications:

Education Minimum Requirement:

• Bachelor Degree in Engineering, Science, Information Technology or other relevant discipline

Required Experience and Skills:

• Six years in process automation or equivalent

• Experience in Automation Platforms such as DCS's (DeltaV), PLCs (Allen Bradley, Siemens), SCADA, OSI PI, Batch Reporting (Informetric Info Batch)

Preferred Experience and Skills:

• Experience with Computer System Validation

#eligibleforerp

VETJOBS

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. 

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Description

Global Project and Alliance Management (GPAM) sits in the Research & Development Division at our company's (known as our Research Laboratories, or our Research Division). The Project Managers in GPAM are core members of development teams at our company, driving these cross-functional teams to deliver projects and products that improve human health and business.

Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our Project & Portfolio management functions which support Development and Commercialization Teams (DCTs) responsible for building and executing CMC development plans.

Under the guidance of the CIPM Director & Portfolio Lead, the core responsibility of this individual will be to lead project management efforts to support Chemistry Manufacturing & Controls (CMC) product development from First in Human to Transfer to Supply, driving line of sight across the development lifecycle and maintaining programs in harmony with the portfolio. In addition, the Senior Specialist will be expected to participate in development of tools and processes to support holistic portfolio management and increased integration of CMC and Clinical strategies.

 Position Description/Summary:

The CIPM Senior Specialist, Project Manager, is a core member of DCTs, partnering with team leads to develop strategies and execute our Company's drug and vaccine development efforts to progress the R&D pipeline. The Senior Specialist is expected to provide project management and drive cross-functional teams with sufficient influence and proficiency to take on assignments with minimal guidance. Projects could span the full CMC development continuum from Line of Sight to First in Human to Transfer to Supply stage-gates.

This position may be based in either Rahway, NJ or Upper Gwynedd, PA.

Primary Responsibilities:

• Independently manage the end-to-end development process for projects that are of moderate complexity and/or work effectively with more senior CIPMs to ensure successful execution of higher complexity development team strategies and project plans.

• Guide teams through the creation, approval, and execution of integrated project plans appropriate to the project's phase of development and complexity.

• Build and maintain project schedules and critical project information, using these tools to integrate activities across key functional areas, work with team leads to proactively identify risks, and ensure clear and effective communication with key team, management, and cross-departmental stakeholders.

• Leverage relationships and networks to improve and enhance team dynamics, with guidance from senior CIPM team members and team leads as needed, to proactively identify and remove obstacles to drive business results.

• Navigate company process and organizational norms to enable teams to understand corporate governance and business requirements, thereby enabling informed decision-making.

• Prepare for and facilitate key team meetings including creating thoughtful agendas, ensuring appropriate participation, contributing project management insights, and following up to ensure the team continues to make progress while holding others accountable.

• Participate in CIPM and GPAM departmental initiatives and workstreams aimed at improving the way that we work and the way that we interact with one another as well as other departments.

Required Education, Experience, and Skills:

• Bachelor’s degree required; concentration in a scientific or applied discipline preferred.

• Minimum of three (3) years of experience in a project management or a related role required.

• Experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing, or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.

• Demonstrated ability to work independently to effectively accomplish goals in a team setting.

• Demonstrated ability to serve as a resource for colleagues and program teams.

• Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others.

• Highly organized and capable of working with attention to detail; Excellent problem-solving skills and ability to build alignment around complex situations.

• Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management.

• Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

Preferred Experience and Skills:

• Experience and knowledge of clinical drug development strongly preferred; including the different phases of development and how the various functional areas contribute to a comprehensive strategy.

• Project management certification (PMP) and/or formal coursework/training in project management strongly preferred

eligibleforERP

#VETJOBS

#ERP

GPAMjobs

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$111,400.00 - $175,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

NA

Job Description

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist – Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.  Responsibilities of the Senior Specialist – Manufacturing Automation include the following:

The automation engineer role at the Senior Specialist level will serve as technical SME and capital team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The automation engineer role at the Specialist level will serve as a team member of the MACS Center Basis of Design Phase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.

As the facility is currently under construction, the selected candidate will contribute to automation equipment and software design, system commissioning/qualification, as well as other automation areas critical activities to enable facility startup. The selected candidate is expected to be a key part of the MACS Project Automation Team and foster a culture of collaboration, learning and innovation. This will also require close collaborate with the development engineers & chemists, compliance representatives, and other team member. This role will be part of the broader Enabling Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.

Additional Supported Areas

As required and in addition to support of current capital projects the Senior Specialist may provide direct support to other areas such as:

Small Scale Organics Pilot Plant (SSO):  The SSO uses an Emerson DeltaV Distributed Control System.  The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization.  The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. 

Hazardous Reactions Lab (HRL):  The Hazardous Reactions Lab (HRL), or Bldg. 801, uses GE PLC 90-30 processors and Genius I/O blocks. The Graphical interface is an Intellution iFix platform run on redundant SCADAS and seven workstations, with historical data collected on a local historian as well as OSI PI.  The B801 High Pressure Lab and Low-Pressure Lab Automation Systems supports Hydrogenation Hazardous reactions using a wide variety of vessels and equipment.  The High-Pressure Barricades Cells are divided up into ten cells where each cell is electrically classified as Class 1 Division 2 Hazardous Area, Group B.

Education Minimum Requirement: 

• Bachelor’s degree in Automation, Engineering, Science, or Computer-Programming related degree with minimum of 5 years relevant experience, or a Masters degree with 3 years of relevant experience

Required Experience and Skills:

• Pharmaceutical Operations experience, in a GMP Pilot Plant, Manufacturing environment or related facility

• Ability to understand, update, design and implement required code modifications in DeltaV

• Experience with automation system design, start-up and/or qualification.

• Experience providing project level direction to contractors and/or third-party vendor staff.

• Knowledge of all of the details of automation including wiring, electrical, device selection and integration

• Experienced problem solver/troubleshooter, skilled in root cause analysis

• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.

• Experience with Quality Systems

• Experience in supporting compliance investigations and change management.

• Familiarity with US and EU GMP and Safety compliance regulations

• Effective interpersonal and communication skills, both verbal and written.

• Excellent organizational skills to multi-task.

• Desire and willingness to learn, contribute and lead.

• Project Management experience with demonstrated skills.

• Candidate must be able to work independently and as part of a cross-functional team.

• Strong analytical thinking and technical writing skills

• Proficient in MS Office Platform and document storage systems

• A high level of innovation, creativity, and self-initiative

Desired Experience and Skills:

• Experience with DeltaV Live, DeltaV wireless and Charms I/O

• Ability to perform PID tuning of instrumentation & control loops.

• Working knowledge of general OPC interfaces

• Subject Matter Expert on Control Systems

• Understanding of Object-Oriented languages

• Strong background in IT systems; specifically, integration of Automation systems with IT systems

• Networking experience; working knowledge of Enterprise Networking and local control networks.

• Experience providing technical mentorship.

• Experience with coordinating maintenance activities around processing activities to support reliable facility operation.

#EBRG

#Vetjobs

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$101,100.00 - $159,100.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A