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.
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