Senior Specialist, Engineering

Senior Specialist, Engineering – Merck

Durham, North Carolina

Join a rapidly growing pharmaceutical manufacturer to provide technical support within a new therapeutic manufacturing facility that includes end-to-end processing of drug substance and product, biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.

• Maintain and ensure reliability of clean utility equipment such as HVAC, Clean steam generators, Water‑For‑Injection systems, reverse osmosis skids, and compressed gas systems.
• Lead deviation investigations for HEPA and HEPA system failures, ensuring well‑investigated, well‑documented events and meeting time commitments.
• Manage small projects for equipment and maintenance improvements, including obtaining quotes, reviewing drawings/specifications, and approving contracts.
• Interact with vendors and support project coordination activities such as design reviews and engineering assessments.
• Identify and resolve technical and operational problems; collaborate with peers to solve cross‑unit issues.
• Assist in identifying, developing, and implementing new systems that enhance operations and engineering processes.
• Adapt and implement departmental plans and priorities based on division scorecard to address local business, service, and operational challenges.
• Consult with next‑level manager on newly identified priorities as needed.
• Develop operating strategy from an Engineering/Maintenance perspective to support site reliability initiatives.

• Oversee improvement projects and implement productivity enhancement initiatives.
• Lead identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost, and maintaining process consistency.
• Anticipate and interpret client and/or customer needs to identify solutions.
• Apply strong problem‑solving skills and a hands‑on approach.

• Fully aware of qualification specifications (IC/OC, IQ/OQ, CRs, etc.).
• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, people).
• Provide input for investigating deviations (both minor and major) and interface with operations, maintenance, automation and quality approvers.
• Present and defend investigations during regulatory inspections as required.
• Support safety initiatives, including shop‑floor audits, lockout/tagout, and Hazardous Energy Control Procedure updates.

• Act as liaison between Engineering, Maintenance, Production, and other site business partners.
• Support daily meetings to facilitate flow of information up/down through the organization.
• Escalate issues as needed to ensure appropriate support and awareness.
• Develop training material and provide necessary training for system maintenance.
• Serve as SME during tours to provide area/process overview to visitors/auditors.

• Ensure inventory/purchase order transactions are complete, timely, and accurate.
• Recognize and communicate opportunities for cost savings.

• Bachelor’s Degree in Engineering or Science with 6 years of experience, or Master’s Degree with 4 years of experience in a production, calibration, or maintenance background.

• Proficient in PI Processbook, Siemens BAS, and Delta
  
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• Project management experience including change control and equipment qualification.
• SAP experience related to plant maintenance and spare parts procurement systems.
• cGMP experience in a sterile, bulk or finished pharmaceutical environment.
• Experience authoring PM/calibration job plans and managing spare parts.
• Mechanical functionality and reliability knowledge (asset management).

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…