Sr. Spclst, Engineering
About The Position
Seeking candidates for a Senior Specialist position within our Company's research laboratories Biologics Pilot Plant (BPP) Equipment Engineering Team. In this individual-contributor role you will lead complex equipment engineering, maintenance strategy, and operational support for pilot-scale GMP manufacturing equipment. Key Responsibilities Act as technical owner for multiple designated equipment systems—drive lifecycle management including maintenance strategy, spare parts optimization, and obsolescence planning. Lead and prioritize corrective maintenance, calibrations, preventative maintenance, and spare parts inventories for assigned equipment to ensure readiness for GMP campaigns. Lead Lock Out / Tag Out, isolation, and other equipment safety procedures; lead root-cause investigations and corrective actions for equipment upsets and events. Author, review, and approve change management documentation (Change Controls, CAPAs, QNs) and provide technical justification where required. Lead small- to medium-scale capital projects from concept through handover (scope, design input, vendor selection, commissioning, and documentation); act as primary liaison with project engineering, procurement, and construction teams. Evaluate, pilot, and recommend new technologies, equipment, and process improvements to enhance throughput, reliability, or compliance. Ensure engineering activities meet regulatory and company safety expectations. Coach and mentor junior engineers; provide technical leadership in multidisciplinary teams and during off-hour manufacturing support as needed. Support audit readiness and respond to regulatory inquiries related to equipment. An understanding of the regulatory guidelines governing GMP operations is important. Candidate is expected to work in a team atmosphere in close collaboration with plant personnel, EM&U, Quality, environmental, and safety groups. Occasionally supporting off-hour manufacturing may be required.
Requirements
- Minimum Requirement: Bachelor’s degree in engineering with 5 years’ experience required, or a master’s degree with 3 years’ experience. Candidates with a bachelor’s degree in a non-technical discipline plus substantial relevant experience in pharmaceutical/biologics equipment management will be considered in lieu of a formal engineering degree.
- Demonstrated experience supporting equipment and/or GMP manufacturing facilities, preferably in biologics or vaccine production.
- Deep working knowledge of cGMP, Quality Systems, and equipment safety requirements as applied to pilot-scale GMP operations.
- Proven experience writing/reviewing technical documentation (protocols, reports, change controls, SOPs).
- Strong problem-solving skills with experience performing root-cause investigations and driving corrective actions.
- Excellent interpersonal skills with demonstrated ability to work effectively in matrixed, cross-functional teams.
- Self-motivated, able to operate independently and prioritize in a fast-paced, dynamic environment.
- Willingness to support off-hour manufacturing and occasional overtime/weekend coverage.
Nice To Haves
- Track record leading capital projects and technical evaluations of new equipment or technologies in a regulated environment.
- Strong project management skills, including scope definition, vendor management, schedule control, and budget awareness.
- Hands-on technical knowledge of pharmaceutical production equipment (fermenters/bioreactors, CIP/SIP systems, filtration/skid-based equipment) and automation controls.
- Experience mentoring staff and driving continuous improvement initiatives.
Responsibilities
- Act as technical owner for multiple designated equipment systems—drive lifecycle management including maintenance strategy, spare parts optimization, and obsolescence planning.
- Lead and prioritize corrective maintenance, calibrations, preventative maintenance, and spare parts inventories for assigned equipment to ensure readiness for GMP campaigns.
- Lead Lock Out / Tag Out, isolation, and other equipment safety procedures; lead root-cause investigations and corrective actions for equipment upsets and events.
- Author, review, and approve change management documentation (Change Controls, CAPAs, QNs) and provide technical justification where required.
- Lead small- to medium-scale capital projects from concept through handover (scope, design input, vendor selection, commissioning, and documentation); act as primary liaison with project engineering, procurement, and construction teams.
- Evaluate, pilot, and recommend new technologies, equipment, and process improvements to enhance throughput, reliability, or compliance.
- Ensure engineering activities meet regulatory and company safety expectations.
- Coach and mentor junior engineers; provide technical leadership in multidisciplinary teams and during off-hour manufacturing support as needed.
- Support audit readiness and respond to regulatory inquiries related to equipment.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
