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.
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