Engineering Project Manager

Contract duration: 3 months/possible extension

The Engineering Project Manager will lead and coordinate the planning, execution, and completion of engineering projects in a commercial mammalian production line. The role focuses on mechanical adaptations and operational improvements, ensuring compliance with GMP standards and integration with production, quality assurance, and EPCM contractors. The Engineering Project Manager will oversee the project lifecycle, from conceptual design through performance qualification (PQ), ensuring timely delivery within scope, budget, and quality requirements.

Responsibilities:

Project Management:

• Lead the end-to-end project lifecycle, including scope definition, budgeting, scheduling, risk management, and project reporting.
• Oversee and coordinate with the EPCM (Engineering, Procurement, and Construction Management) contractor to ensure successful execution of mechanical adaptations.
• Monitor and report on project progress against agreed milestones, addressing issues and implementing corrective actions when required.

Stakeholder Coordination:

• Act as the central point of contact for project stakeholders, including the Technical Project Lead, production staff, quality assurance teams, and external contractors.
• Facilitate collaboration between operational teams and EPCM to align engineering deliverables with production and quality requirements.
• Ensure alignment with GMP change management protocols, including TCRs (Temporary Change Requests) and CRs (Change Requests).

Compliance & Documentation:

• Ensure adherence to GMP regulations, company policies, and industry standards throughout the project lifecycle.
• Collaborate with quality assurance teams to ensure project deliverables meet all regulatory requirements.
• Maintain comprehensive project documentation, including risk assessments, design reviews, and performance qualification (PQ) records.

Resource Management:

• Manage project resources, including internal staff and external contractors, to ensure timely and efficient project execution.
• Develop and manage the project budget, tracking expenditures and addressing variances proactively.

Performance Qualification (PQ):

• Oversee and coordinate performance qualification (PQ) activities, ensuring the system meets intended operational and regulatory requirements.
• Collaborate with production staff during PQ to validate operational improvements and mechanical adaptations.

Requirements:

• Bachelor’s degree in Engineering (Mechanical, Process, Chemical, or related field). Master’s degree is a plus.
• Minimum of 5–7 years of experience in project management within a biopharmaceutical or regulated manufacturing environment.
• Proven track record of managing GMP-compliant engineering projects from design to qualification.
• Experience working with EPCM contractors and cross-functional teams, including operations and quality assurance.
• Strong project management skills, including budgeting, scheduling, and risk management.
• Excellent knowledge of GMP regulations and change management protocols (TCRs and CRs).
• Exceptional communication and stakeholder management skills.
• Proficiency in project management tools and software (e.g., MS Project, Primavera).
• Strong problem-solving and decision-making capabilities.
• PMP (Project Management Professional) certification.
• Lean Six Sigma or other operational excellence certifications are a plus.