CAPEX Project Manager

SIRE® Life Sciences ?; Oss; On-site; EUR 90,000 - 140,000; Full time

Job summary

SIRE Life Sciences is seeking an experienced Project Manager to oversee and deliver complex capital investment projects at a major pharmaceutical production facility. The role entails managing projects from conception through completion, ensuring alignment with strategic, operational, and safety standards.

Responsibilities include leading cross-functional teams, managing budgets and timelines (3–5 years), ensuring GMP compliance, and providing clear updates to sponsors and stakeholders.

Qualifications

• Proven experience in managing large-scale capital projects in a pharmaceutical or GMP environment.
• Strong leadership and the ability to motivate multidisciplinary teams.
• Excellent stakeholder management and communication abilities.
• Solid understanding of GMP standards, validation, and qualification processes.
• Ability to manage budgets, schedules, and risk assessments.
• Proficiency in Dutch and English.

Responsibilities

• Lead end-to-end management of large-scale CAPEX projects within a GMP environment.
• Translate strategy into clear project plans, scope, and deliverables.
• Advise senior management on investment decisions, risks, and priorities.
• Manage multidisciplinary project teams with engineering, quality, SHE, finance, maintenance, procurement, and EPCM partners.
• Develop and monitor project scope, budgets, timelines (3-5 years), quality criteria, and safety standards.
• Identify risks and implement mitigation strategies; oversee stage-gate decisions.
• Ensure GMP compliance, qualification, and validation procedures.
• Coordinate design, feasibility studies, construction, installation, qualification, and validation.
• Deliver comprehensive project documentation, including as-built drawings and training plans.
• Act as liaison between sponsors, project teams, management, and external stakeholders.
• Build relationships with contractors, suppliers, and external agencies.
• Provide transparent updates on progress, risks, issues, and key decisions.

Skills

Project management

Leadership

Stakeholder management

GMP knowledge

Communication

Job description

Our client is a global health care company that originated from a spin-off. Today they provide more than 60 pharmaceuticals and other products across a range of therapeutic areas, including reproductive health, heart disease, dermatology, allergies and asthma. They make these treatments available around the world, by serving people in many countries.

Job Description

We are seeking an experienced Project Manager to oversee and deliver complex capital investment projects at a major pharmaceutical production facility. This role involves managing projects from conception through to completion, ensuring they meet strategic, operational, and safety standards.

Responsibilities

• Lead end-to-end management of large-scale CAPEX projects within a GMP environment, including site expansions, process improvements, new product launches, and equipment replacements.
• Translate strategic business objectives into clear project plans, scope, and deliverables.
• Advise senior management on investment decisions, risks, and project priorities.
• Manage multidisciplinary project teams, working closely with engineering, quality, SHE, finance, maintenance, procurement, and external partners such as EPCM contractors.
• Develop and monitor project scope, budget, timelines (3-5 years), quality criteria, and safety standards.
• Identify project risks, implement mitigation strategies, and oversee decision points like stage gates.
• Ensure all project activities comply with GMP standards, qualification, and validation procedures.
• Coordinate technical activities including design, feasibility studies, construction, installation, qualification, and validation.
• Deliver comprehensive project documentation, including as-built drawings, maintenance plans, and operator training.
• Act as the primary liaison between sponsors, project teams, management, and external stakeholders.
• Build strong relationships with contractors, suppliers, and external agencies.
• Provide transparent updates on project progress, risks, issues, and key decisions.

Requirements

• Proven experience in managing large-scale capital projects in a pharmaceutical or GMP environment.
• Strong leadership skills, with the ability to motivate multidisciplinary teams.
• Excellent stakeholder management and communication abilities.
• Solid understanding of GMP standards, validation, and qualification processes.
• Ability to manage budgets, schedules, and risk assessments effectively.
• Proficiency in Dutch and English