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100% on-site work required in Newark, DE; applicants must be local.
Job Summary:
100% on-site work required in Newark, DE; applicants must be local.
Job Summary:
- Lead end-to-end capital projects for pharmaceutical utilities and facility systems (e.g., HVAC, clean utilities, WFI, clean steam) ensuring project scope, schedule, and budget compliance.
- Manage multiple engineering projects, including facility upgrades, infrastructure improvements, packaging, and inspection system installations.
- Provide technical leadership and ensure compliance with GMP regulations, CQV (Commissioning, Qualification, Validation), and validation requirements for facility and utility projects.
- Develop, monitor, and control capital budgets, forecasts, and financial performance across various projects.
- Oversee construction activities, including contractor management, bid evaluation, field coordination, and ensuring safety compliance.
- Ensure strict adherence to project governance, design reviews, change control processes, and documentation of validation activities (IQ/OQ/PQ).
- Collaborate with internal teams (Facilities, Manufacturing, Quality, Validation, and EHS) to ensure site readiness and operational reliability.
- Manage relationships with external vendors, contractors, and engineering firms to guarantee quality, safety, and timely completion of projects.
- Require a Bachelor’s degree in Engineering and 7–10 years of relevant experience in pharmaceutical/biotech facilities project management.
- Advanced skills in project scheduling (Microsoft Project or similar), budgeting, cost control, and a deep understanding of GMP, pharmaceutical utilities, and equipment qualification.