Overview We are seeking an experienced Lead Process Engineer to provide technical and project leadership for the deployment of process equipment within a GMP-regulated biopharmaceutical manufacturing environment. This role will oversee equipment delivery, installation, integration, commissioning, qualification, and operational handover while ensuring compliance with quality, safety, and regulatory requirements.
Responsibilities - Lead process equipment implementation projects from planning through operational handover.
- Manage project schedules, change controls, risk assessments, and cross-functional coordination activities.
- Oversee equipment delivery, installation, commissioning, startup activities, and punch-list resolution.
- Support asset onboarding, calibration programs, preventive maintenance planning, and spare parts management.
- Coordinate integration activities with automation, process control systems, digital systems, and computerized system validation (CSV) teams.
- Lead qualification activities, discrepancy investigations, and lifecycle documentation development.
- Ensure operational readiness through training coordination, EHS reviews, GMP release activities, and successful turnover to operations.
- Collaborate with Manufacturing, Engineering, Quality, Validation, Facilities, and Project Management teams to deliver project objectives.
Qualifications - Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical discipline.
- Minimum 8+ years of engineering experience within the pharmaceutical, biotechnology, or life sciences industry.
- Proven experience leading process equipment deployment projects in GMP manufacturing environments.
- Strong knowledge of commissioning, qualification, validation, and GMP compliance requirements.
- Experience with single-use technologies, process equipment integration, and manufacturing operations.
- Demonstrated project leadership skills with the ability to manage multiple stakeholders and priorities.
- Excellent communication, problem-solving, and documentation skills.
Preferred Qualifications:
- Experience with automation systems, process control systems (PCS), and computerized system validation (CSV).
- Knowledge of equipment lifecycle management, operational readiness, and manufacturing startup activities.
- Prior experience supporting capital projects in a biopharmaceutical manufacturing environment.
Pay Range Disclosure: The pay range for this position is $120,000 - $160,000 annually. This range represents the base salary that PM Group reasonably expects to pay for this role at the time of posting. The actual compensation offered will depend on factors such as work location, qualifications, skills, and relevant experience.
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