Purpose:
- Lead the process engineering effort for multiple strategic biopharmaceutical capital projects as owner-side Design Authority.
- Provide technical leadership, governance, and oversight for process engineering activities for large-scale manufacturing facility projects, ensuring designs and deliverables meet corporate standards, regulatory expectations, and operational requirements.
Responsibilities:
- Lead SME team to drive A&E consultant engineering schedules; ensure deliverables are reviewed, approved, and issued for design/construction to avoid project interruption.
- Provide senior process engineering leadership; coordinate owner process engineering team with contractor engineering.
- Establish execution strategies/technical standards; ensure alignment with manufacturing, regulatory, and corporate standards.
- Govern/approve key deliverables: PFDs, P&IDs, cause & effect diagrams, process schematics/system architecture, control narratives, and operations philosophy documentation.
- Lead multidisciplinary design reviews; ensure cross-discipline consistency (process, mechanical, utilities, automation, facility systems).
- Oversee process system architecture, integration with utilities/automation/cleanroom & environmental systems, and process fluid/line list development and verification.
- Provide PSM/process safety oversight (relief sizing, overpressure protection, PHA, HAZOP); review safety-critical analyses.
- Develop/approve operations philosophy; support safe startup/shutdown/maintenance/cleaning and human factors/maintainability.
- Support turnover to CQV; resolve commissioning/qualification issues; monitor contractor performance; oversee budgets/resources; support cost estimates/schedules; identify/mitigate risks; lead high-performing project organization.
Qualifications:
- BS in Engineering or equivalent; Masterβs in Engineering or MBA preferred.
- 10+ years as Senior Engineering/Projects/Operations leader across multiple technologies.
- Proven leadership on mega-capital projects ($500MMβ$1B+); deep biopharmaceutical engineering systems knowledge.
- Experience managing engineering contractors/global vendors; inclusive leadership; strong negotiation and risk-based decision making.
- Ability to mentor leaders; travel within and outside the US as needed.
Benefits (if eligible):
- Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.