Senior Engineering Project Manager

Your Responsibilities

Project Management:

• Ensure design intent is maintained through all phases (basic design detailed design execution).
• Review and approve design documents, drawings, and equipment specifications to confirm technical quality and constructability.
• Monitor and control project scope, schedule, cost, and risk, including change management (TCRs, CRs).
• Facilitate design coordination between EPCM, internal engineering teams, quality assurance and operations.
• Support procurement activities (long-lead equipment) to ensure alignment with design and construction sequencing.

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.

Your Background

• Bachelor's degree in Engineering (Mechanical, Process, Chemical, or related field). Master's degree is a plus.
• 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.