Senior Specialist, Engineering

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

The Senior Specialist, Engineer is a member of the Engineering team providing technical support within a new therapeutic manufacturing facility located in Durham, North Carolina. The new facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. The candidate will be responsible/support the reliability, operation, and maintenance of HVAC and clean utility equipment and systems (WFI, Clean Steam, HVAC, and CDA), utility equipment and systems (Boilers, Chillers, etc.)

to ensure proper functionality of manufacturing equipment such as washers, autoclaves, filling line, lyophilizers and isolators. The successful candidate will also develop Standard Operating Procedures (SOPs), Preventative Maintenance (PM) plans as necessary and be responsible for supporting root cause investigations and change control activities.

• Responsible for the maintenance and reliability of Clean Utility Equipment (e.g. HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems)
• Leads deviation investigations for HEPA and HEPA system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments
• Manages small projects for equipment/maintenance-related improvements, including obtaining quotes, drawing/specification review/approval, and review of contracts
• Interact with vendors and support project coordination activities like design reviews, and engineering assessments
• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
• Responsible for assisting in the identification, development, and implementation of new systems which enhance the operation and/or engineering processes.
• Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges
• Consults on an as-needed basis with next-level manager for newly identified priorities
• Develops operating strategy from an Engineering / Maintenance perspective supporting site reliability initiatives

• Oversee improvement projects and implementation of productivity enhancement initiatives.
• Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency
• Anticipates and interprets client and/or customer needs to identify solutions
• The successful candidate must have strong problem-solving skills and a hands‑on approach to problem solving.

• Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)
• The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root causes.
• Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, Maintenance, Automation, and Quality approvers.
• As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
• Actively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates

• Works as a liaison between Engineering, Maintenance, Production and other Site Business Partner's
• Support daily meetings to facilitate flow of information up/down through the organization
• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise
• Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance.
• Serve as a Subject Matter Expert during tours to provide area/process overview information to…