Key Responsibilities
* Lead the completion of detailed design in accordance with project scope, GMP standards, and deliverables
* Maintain the integrity of the design intent throughout all project phases
* Review and approve technical documents, drawings, and specifications for quality and feasibility
* Monitor project scope, timeline, budget, and risks, including handling change requests
* Coordinate design activities among EPCM contractors, internal engineering teams, quality assurance, and operations
* Support procurement processes, especially for long-lead equipment, aligning them with project plans
* Ensure adherence to GMP regulations, company policies, and industry standards during all project stages
* Collaborate with QA teams to ensure compliance with regulatory requirements
* Maintain thorough project documentation such as risk assessments, design reviews, and qualification records
* Manage project resources, including internal staff and external contractors, to meet deadlines
* Develop and oversee project budgets, tracking expenses and addressing variances
* Supervise performance qualification (PQ) activities, validating operational and regulatory compliance
* Work closely with production teams during PQ to confirm operational improvements and system performance