Shutdown Project Manager; Pharma/Biotech - Life Science
Job in
Thousand Oaks, Ventura County, California, 91362, USA
Listed on 2026-06-01
Listing for:
CyberCoders
Full Time
position Listed on 2026-06-01
Job specializations:
-
Engineering
Systems Engineer, Quality Engineering, Operations Engineer, Pharma Engineer
Job Description & How to Apply Below
Shutdown Project Manager (Pharma/Biotech)
Location:
Thousand Oaks, CA
Salary: $150K-$240K base (salary depends on experience)
Position Overview
Lead and own planned shutdowns, turnarounds, and critical maintenance projects for pharmaceutical and biotechnology facilities. The Shutdown Project Manager will plan, coordinate, and execute multi-disciplinary shutdown work to meet safety, regulatory (cGMP/FDA/EMA), and schedule objectives while managing budget, stakeholders, contractors, and validation activities to resume production on time and compliant.
Key Responsibilities
- Plan and manage end-to-end shutdowns, turnarounds, and major maintenance windows in pharma/biotech facilities, ensuring on-time, on-budget and compliant execution.
- Develop detailed shutdown schedules, phased work plans and resource loading using Primavera P6 and MS Project; integrate contractor, maintenance and validation activities.
- Lead pre-shutdown planning including scope definition, risk assessments, procurement, materials staging, and readiness reviews.
- Coordinate cross-functional teams (engineering, operations, quality, validation, EHS, facilities) and external contractors to align work packages and interfaces.
- Manage Validation Master Plan activities during shutdowns: IQ/OQ/PQ sequencing, equipment requalification, and documentation to meet cGMP/FDA/EMA requirements.
- Implement and enforce safety, isolation/tagout, and EHS requirements during all shutdown phases; lead pre-job briefings and lessons-learned.
- Control project budgets, change orders and capital spending; prepare cost forecasts, track expenditures and justify contingency use.
- Maintain strict change control, documentation, and regulatory traceability for all maintenance, modification and commissioning work.
- Use PLC/SCADA knowledge where required to coordinate control system shutdown/bring-up procedures with automation teams.
- Provide clear status reporting to senior stakeholders, prepare post-shutdown reports, drive continuous improvement and update shutdown playbooks.
- Bachelors degree in Engineering, Construction Management, Life Sciences or related field required; advanced degree preferred.
- Minimum 7 years project management experience with at least 3 full shutdown/turnaround cycles in pharmaceutical or biotech facilities.
- Proven knowledge of life science manufacturing and cleanroom environments, including cGMP requirements and experience with FDA/EMA inspections or audits.
- Strong schedule management experience with Primavera P6 and Microsoft Project; demonstrated ability to build, compress and recover complex schedules.
- Experience managing Validation Master Plan activities and equipment requalification (IQ/OQ/PQ) during shutdowns.
- Familiarity with PLC, SCADA, and industrial control system coordination during shutdown and restart activities.
- Demonstrated ability to manage capital projects, contractors, and supply chain for mission-critical and clean room work.
- Excellent stakeholder management, communication skills, and experience leading cross-functional teams under time pressure.
- Preferred: experience across Laboratory, VMP, Data Center, Commercial, Industrial, Ground-Up/New Construction, Public Works, Educational, High Rise, Addition, Lab, Healthcare, Medical, Hospital, Pharmaceutical and Biotech projects.
- Certifications preferred: PMP or equivalent project management certification; experience with Quality/Compliance certifications a plus.
Full Benefits Included
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