Project Engineer II, GMP Pharmaceutical Capital Projects
Overview
You own capital projects from concept through startup and qualification in a GMP-regulated pharmaceutical manufacturing environment, impacting production of topical and inhalable generic drugs. You manage scope, schedule, budget, and vendors across cross-functional teams. GMP compliance, FDA standards, and ALCOA+ data integrity anchor every deliverable. You lead design reviews, validation (IQ/OQ/PQ), and change control, mentoring junior engineers. This role offers direct exposure to large-scale equipment installs and process optimization in a high-growth generic pharma setting.
What You'll Do10
- 1Lead capital projects from concept through commissioning, qualification, and operational handover, ensuring GMP and FDA compliance.
- 2Define project scope, schedule, budget, and resources, then drive execution to meet milestones within first 90 days.
- 3Manage vendors and contractors, overseeing procurement and delivery to keep capital projects on track.
- 4Identify risks and implement mitigation strategies, resolving issues to protect timeline and budget.
- 5Lead design reviews and approve engineering deliverables for process, safety, and operational alignment.
- 6Oversee installation, commissioning, and startup of manufacturing equipment, troubleshooting as needed.
- 7Own change control activities, including impact assessment and implementation planning under GMP.
- 8Drive validation and qualification (IQ/OQ/PQ) to ensure systems pass regulatory inspection.
- 9Document all work per ALCOA+ data integrity standards, from URS to final reports.
- 10Mentor junior engineers and coordinate with Quality, Validation, and Maintenance teams.
Requirements10
- 13-6 years executing capital projects in manufacturing environments.
- 25+ years in regulated environments, preferably pharmaceutical or medical device.
- 3Bachelor's degree in Chemical, Mechanical, Biomedical, or Industrial engineering.
- 4Hands-on equipment installation, commissioning, and troubleshooting experience.
- 5Strong knowledge of GMP and FDA quality system requirements.
- 6Proven expertise in validation protocols (IQ/OQ/PQ) and change control.
- 7Familiarity with ALCOA+ principles for data integrity.
- 8Excellent cross-functional collaboration with manufacturing, quality, and validation teams.
- 9Demonstrated ability to mentor junior staff and drive process improvements.
- 10Strong communication skills for reporting and stakeholder updates.
Salary Insight
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