Operations Lead (Shop Floor Supervisor)

MSD Malaysia; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a motivated professional to join the MACS Center within CERD, gaining pilot plant operations experience and a solid foundation in engineering principles.

You will contribute to scale-up efforts, support startup phases, and help project teams meet performance goals. You will supervise daily production activities, coordinate maintenance, and work with cross-functional partners to ensure facility readiness for API processing while upholding safety, quality, and

Qualifications

• Bachelor's degree in Chemical Engineering or related field with 2+ years in a process development lab or pilot plant/ manufacturing facility.
• High school diploma with 6+ years relevant experience in a process development lab or pilot plant/manufacturing facility.

Responsibilities

• Serve as an operations team member supporting the MACS Center.
• Support a fellow operations team member from testing and startup through to full operation of MACS facility.
• Assist in expanding capabilities across the SM PR&D network as needed.
• Contribute to equipment and facility design, system commissioning/qualification, and startup activities.
• Supervise and participate in daily production activities while ensuring safety, GMP, and environmental compliance.
• Prioritize and assign daily activities for the operations staff.
• Implement process improvements to meet S&E and GMP requirements.
• Ensure facility readiness for API processing and collaborate with leadership and cross-functional partners.

Skills

Mechanical aptitude

Team supervision

cGMP & GDP

Equipment operation

Communication

Conflict resolution

Team collaboration

Shift rotation

Adaptability

Education

Bachelor's in Chemical Engineering

High school diploma + 6 years experience

Tools

DeltaV

PLC

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.

Responsibilities

• Serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center.
• Support an operations team member from testing and startup through to when the MACS facility is fully operational.
• Potentially support other new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.
• Contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup.
• Supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements to meet MACS objectives and customer requirements.
• Prioritize and assign daily activities for the operations staff.
• Implement process improvement actions to meet S&E (Safety & Environmental) and GMP requirements.
• Ensure facility readiness for API (Active Pharmaceutical Ingredient) processing and share accountability for the facility’s performance.
• Work cooperatively with MACS leadership team and cross-functional partners to drive overall success and performance of the building.

Additional Supported Areas

• 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. — OR— 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).
• 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.

Equal Employment Opportunity Statement

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: EEOC Know Your Rights EEOC GINA Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts

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.

Salary and Benefits

The salary range for this role is $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.

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.

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