Project Manager (OPEX /CAPEX)

Proclinical is seeking a Project Manager to lead the integration of capital expenditures (CapEx) and operational improvements (OpEx) in a mammalian commercial production line. This role involves coordinating between engineering, procurement, and construction management (EPCM) contractors and internal production teams to ensure project success and compliance.

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:

• Serve as the main point of accountability for project alignment between EPCM activities and production initiatives.
• Develop and manage a comprehensive project plan, integrating timelines and deliverables.
• Coordinate cross-functional teams to ensure smooth communication and collaboration.
• Establish clear roles and responsibilities for stakeholders.
• Act as the central contact for seamless communication between EPCM, production staff, and other stakeholders.
• Manage GMP change control processes for CapEx and OpEx activities.
• Oversee EPCM contractor performance and ensure adherence to specifications and quality standards.
• Drive compliance with GMP change management requirements.
• Coordinate the transition from mechanical adaptations to operational improvements.
• Maintain detailed project documentation and provide regular updates to senior management.
• Oversee planning and execution of validation activities in alignment with regulatory requirements.

Key Skills and Requirements:

• Bachelor's degree in Engineering, Biotechnology, or related field.
• Strong project management skills with experience in CapEx projects within a GMP-regulated environment.
• Solid understanding of GMP principles and change management procedures.
• Strong leadership and team management abilities.
• Excellent organizational and problem-solving skills.
• Exceptional communication and stakeholder management skills.
• Proficiency in project management tools (e.g., MS Project, Primavera).
• PMP or PRINCE2 certification preferred; Lean Six Sigma certification is a plus.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at [email protected]

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, 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.