Operations Lead (Shop Floor Supervisor)

Merck & Co.; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck & Co., Rahway, NJ, is seeking a Specialist-Process Supervisor to join the MACS Operations Team in a fast-paced pilot plant environment. The role supports the MACS Center and participates from testing and startup through full operation while collaborating with the SM PR&D network to enable facility startup and ensure safety, GMP, and environmental compliance.

This position requires leadership of daily activities, prioritization of staff work, and readiness for equipment qualifications as

Qualifications

• Mechanical aptitude and familiarity with chemical process development and process equipment.
• Supervising a team of shop floor personnel in an operations environment.
• Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.
• Experience operating/maintaining manufacturing scale, pilot scale, and/or lab scale equipment.
• Effective communication skills and a collaborative mindset.
• Experience in conflict resolution and root cause analyses.
• Ability to build effective work relationships with a varied workforce.
• Adaptable to a dynamic production environment.
• As the building transitions towards equipment qualifications and operations must be able to rotate between 1st and 2nd shift on a weekly basis.
• Desire and willingness to learn, contribute and lead.
• Coordinating maintenance activities around processing activities to support reliable facility operation.
• Working in an environment with Automation Systems (DeltaV, PLC, etc.).

Responsibilities

• Supervise and participate in daily production activities while ensuring Safety, GMP Quality, and Environmental requirements to meet MACS objectives and customer requirements.
• Prioritize and assign daily activities for the operations staff and support facility startup.
• Implement process improvement actions to meet S&E and GMP requirements.
• Rotate between 1st and 2nd shift on a weekly basis as the building transitions toward qualification and operation.

Skills

Mechanical aptitude

Team supervision

cGMP GDP S&E

Scale equipment operation

Communication skills

Conflict resolution

Cross-functional collaboration

Adaptability

Automation systems (DeltaV PLC)

Education

Bachelor's degree in Chemical Engineering or related field

High school diploma with 6+ years relevant experience

Job description

Job Description

The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides pilot plant operations experience and a strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director, MACS Operations and will be a member of the MACS Operations Team at the Rahway, NJ facility. Responsibilities of the Specialist-Process Supervisor include the following: The process supervisor role at the Specialist level will serve as an operations 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 under construction in Rahway, New Jersey. The Specialist will serve as a team member from testing and startup through to when the MACS facility is fully operational. They will also potentially support other new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. (see "Additional Supported Areas") As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. The selected candidate is expected to be a key part of an operations team and foster a culture of collaboration, learning and innovation. The incumbent will supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements to meet MACS objectives and customer requirements. This role will also be responsible for the prioritization and assignment of daily activities for the operations staff. The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements. This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the facility's performance. Ultimately, this position is expected to work cooperatively with the MACS leadership team and cross-functional MACS partners to drive overall success and performance of the building.

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 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.

Prep Lab Area

The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.

Education Minimum Requirement:

• Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment.

• High school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.

Required Experience and Skills:

• Mechanical aptitude and familiarity with chemical process development and process equipment.
• Supervising a team of shop floor personnel in an operations environment
• Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.
• Experience operating/maintaining manufacturing scale, pilot scale, and/or lab scale equipment.
• Effective communication skills and a collaborative mindset.
• Experience in conflict resolution and root cause analyses.
• Ability to build effective work relationships with a varied workforce.
• Adaptable to a dynamic production environment.
• Relevant experience in a process development lab or pilot plant/manufacturing facility.
• As the building transitions towards equipment qualifications and operations must be able to rotate between 1st and 2nd shift on a weekly basis.
• Desire and willingness to learn, contribute and lead.
• Coordinating maintenance activities around processing activities to support reliable facility operation.
• Working in an environment with Automation Systems (DeltaV, PLC, etc.).

Desired Experience and Skills:

• GMP facility design, equipment start-up and/or qualification.
• Small molecule drug substance and/or biologics process development.
• Supporting compliance investigations and change management.
• Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)
• Potent Compound processing and containment systems (e.g., isolators).
• Interacting with process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
• Quality systems notifications, Root Cause Analysis (RCA), Corrective Action Preventative Action (CAPA), quality change controls, and/or safety Management of Change (MOC).

Required Skills:

cGMP Guidelines, Competency Management, Corrective Action Management, Electronic Batch Records, Manpower Planning, Manufacturing Processes, Pilot Plant Operations, Process Engineering, Root Cause Identification, Root Cause Investigations, Troubleshooting

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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

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Salary Range

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/23/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R417167