Overview Join a dynamic team at a leading Contract Manufacturing Organisation and contribute to groundbreaking projects and cutting-edge solutions.
Proclinical is seeking a Senior Engineering Project Manager to lead the transition from detailed design to construction and qualification of mechanical adaptations within an existing GMP commercial mammalian production line. This role focuses on ensuring project deliverables are met while maintaining compliance with GMP regulations and industry standards.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities Drive the completion of detailed design in alignment with project scope, deliverables, and GMP requirements.
Ensure design intent is preserved through all project phases, including basic design, detailed design, and execution.
Review and approve design documents, drawings, and equipment specifications for technical quality and constructability.
Monitor and control project scope, schedule, cost, and risk, including managing changes (TCRs, CRs).
Facilitate design coordination between EPCM contractors, internal engineering teams, quality assurance, and operations.
Support procurement activities for long-lead equipment to align with design and construction sequencing.
Ensure adherence to GMP regulations, company policies, and industry standards throughout the project lifecycle.
Collaborate with quality assurance teams to meet regulatory requirements.
Maintain comprehensive project documentation, including risk assessments, design reviews, and performance qualification (PQ) records.
Manage project resources, including internal staff and external contractors, to ensure timely and efficient execution.
Develop and manage the project budget, tracking expenditures and addressing variances proactively.
Oversee and coordinate PQ activities to validate operational improvements and mechanical adaptations.
Key Skills and Requirements Degree in Engineering (Mechanical, Process, Chemical, or related field); advanced degree preferred.
Proven experience managing GMP-compliant engineering projects from design to qualification.
Familiarity with EPCM contractors and cross-functional teams, including operations and quality assurance.
Strong project management skills, including budgeting, scheduling, and risk management.
Knowledge of GMP regulations and change management protocols (TCRs, CRs).
Proficiency in project management tools (e.g., MS Project, Primavera).
Exceptional communication and stakeholder management skills.
Problem-solving and decision-making capabilities.
PMP certification and/or Lean Six Sigma certification is a plus.
Fluency in English is required; German proficiency is preferred.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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