Proclinical is seeking a Technical Project Manager to oversee capital investment projects within a commercial mammalian cell production line. This role requires a blend of technical expertise, operational excellence, and project management skills to ensure successful project delivery. The successful candidate will act as the main liaison between operational teams, quality assurance, and engineering teams managing the EPCM contractor.
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: Define technical requirements and success criteria, ensuring alignment with GMP standards and operational goals.
Collaborate with stakeholders to integrate operational improvements into project plans.
Develop a comprehensive project lifecycle roadmap from design to performance qualification.
Serve as the primary technical contact, ensuring mechanical adaptations meet specifications.
Coordinate with EPCM teams to align engineering deliverables with project needs.
Support production staff in implementing operational improvements.
Ensure compliance with GMP regulations and manage change control processes.
Facilitate cross-functional communication to integrate mechanical adaptations into production.
Monitor project progress, conduct risk assessments, and provide regular updates.
Lead equipment commissioning and qualification activities, coordinating with validation teams.
Key Skills and Requirements: Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or related field.
Experience in biopharmaceutical manufacturing with a focus on project management.
Knowledge of GMP-compliant projects and change management.
Hands-on experience in commissioning, qualification, and validation in a GMP environment.
Proficiency in project management tools and methodologies.
Strong problem-solving, communication, and organizational skills.
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