Sr. Spclst, Engineering
Merck
2 hours ago
On-site
West Point, PA
Operations
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.
Education Minimum Requirement:
- Bachelor’s degree in engineering with 5 years’ experience required, or master’s degree with 3 years’ experience.
- Bachelor’s in a non-technical discipline plus substantial relevant experience in pharmaceutical/biologics equipment management may be considered in lieu of a formal engineering degree.
Required Experience and Skills:
- 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 for pilot-scale GMP operations.
- Proven experience writing/reviewing technical documentation (protocols, reports, change controls, SOPs).
- Strong problem-solving skills with root-cause investigations and corrective actions.
- Excellent interpersonal skills working 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.
Preferred Experience and Skills:
- Track record leading capital projects and technical evaluations of new equipment/technologies in a regulated environment.
- Strong project management skills (scope, vendor management, schedule control, budget awareness).
- Hands-on knowledge of pharmaceutical production equipment (fermenters/bioreactors, CIP/SIP, filtration/skid-based) and automation controls.
- Experience mentoring staff and driving continuous improvement.
Required Skills (as listed):
- Analytical Testing, Capital Projects, Corrective Maintenance, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Machinery Safety, Maintenance Strategy, Manufacturing Automation, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Engineering, Project Management, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).
- Apply by the application deadline stated on the posting.
- 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.
Education Minimum Requirement:
- Bachelor’s degree in engineering with 5 years’ experience required, or master’s degree with 3 years’ experience.
- Bachelor’s in a non-technical discipline plus substantial relevant experience in pharmaceutical/biologics equipment management may be considered in lieu of a formal engineering degree.
Required Experience and Skills:
- 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 for pilot-scale GMP operations.
- Proven experience writing/reviewing technical documentation (protocols, reports, change controls, SOPs).
- Strong problem-solving skills with root-cause investigations and corrective actions.
- Excellent interpersonal skills working 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.
Preferred Experience and Skills:
- Track record leading capital projects and technical evaluations of new equipment/technologies in a regulated environment.
- Strong project management skills (scope, vendor management, schedule control, budget awareness).
- Hands-on knowledge of pharmaceutical production equipment (fermenters/bioreactors, CIP/SIP, filtration/skid-based) and automation controls.
- Experience mentoring staff and driving continuous improvement.
Required Skills (as listed):
- Analytical Testing, Capital Projects, Corrective Maintenance, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Machinery Safety, Maintenance Strategy, Manufacturing Automation, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Engineering, Project Management, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).
- Apply by the application deadline stated on the posting.