Technical Project Manager
We are seeking a skilled Technical Project Manager to lead capital investment projects within our 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.
Key Responsibilities:
* Project Planning and Execution
o Define technical requirements and success criteria, ensuring alignment with GMP standards and operational goals.
o Collaborate with stakeholders to integrate operational improvements into project plans.
o Develop a comprehensive project lifecycle roadmap from design to performance qualification.
* Stakeholder Management
o Serve as the primary technical contact, ensuring mechanical adaptations meet specifications.
o Coordinate with EPCM teams to align engineering deliverables with project needs.
* Quality and Compliance
o Ensure compliance with GMP regulations and manage change control processes.
o Facilitate cross-functional communication to integrate mechanical adaptations into production.
* Project Monitoring and Control
o Monitor project progress, conduct risk assessments, and provide regular updates.
o Lead equipment commissioning and qualification activities, coordinating with validation teams.
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.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.