Job description
Mission Description
As a CAPEX Project Manager in the pharmaceutical sector, you will be responsible for leading investment projects (new facilities, equipment, utilities, laboratories, production lines, etc.) from concept to handover, ensuring they are delivered on time, within budget, and in compliance with GMP and all applicable regulations.
Your main responsibilities will include:
Project Planning & Execution- Define project scope, objectives, and deliverables for CAPEX projects (greenfield, brownfield, revamping, equipment upgrades).
- Develop and maintain detailed project plans, schedules, and budgets.
- Coordinate all project phases: feasibility, basic design, detailed design, procurement, construction, commissioning, qualification, and handover to operations.
CAPEX Management & Budget Control- Prepare CAPEX requests, business cases, and investment justifications.
- Monitor project costs, manage forecasts, and ensure adherence to approved budgets.
- Challenge suppliers’ offers and change orders, ensuring cost-effectiveness and value for money.
Team Leadership & Coordination- Lead cross-functional project teams (engineering, production, quality, validation, HSE, maintenance, procurement).
- Coordinate external partners: engineering firms, construction companies, equipment vendors, and integrators.
- Organize and facilitate project meetings, ensuring clear roles, responsibilities, and follow-up of actions.
Stakeholder Management & Communication- Act as the primary point of contact for project stakeholders, including site leadership and global functions.
- Provide regular updates on project progress, milestones, risks, and issues.
- Prepare and present project status reports and decision papers to steering committees and senior management.
Risk Management & HSE- Identify, assess, and manage project risks (technical, financial, planning, regulatory).
- Implement mitigation plans and contingency strategies.
- Ensure strict adherence to HSE standards during design and execution (construction safety, process safety, ergonomics).
Compliance, Quality & Validation- Ensure that all CAPEX projects comply with GMP/GxP, FDA/EMA and local regulatory requirements, as well as internal quality standards.
- Coordinate qualification and validation activities (IQ/OQ/PQ) in collaboration with Quality and Validation teams.
- Ensure proper documentation (URS, FS, DS, FAT/SAT, validation protocols and reports) is created, reviewed, and archived.
Resource & Contractor Management- Define resource needs and allocate internal and external resources effectively.
- Manage contractor performance, ensuring compliance with contracts, quality, safety, and planning.
- Participate in vendor selection, technical evaluations, and contract negotiations.
Innovation & Continuous Improvement- Promote innovative technical solutions (automation, digitalization, energy efficiency, sustainable design).
- Identify and implement best practices in CAPEX project management and engineering.
- Contribute to the continuous improvement of project management methodologies, tools, and standards.
Reporting & Documentation- Prepare comprehensive project documentation: charters, schedules, budgets, risk registers, progress reports, and closing reports.
- Ensure proper handover to operations and maintenance, including training, documentation, and spare parts lists.
- Capture lessons learned and contribute to the project portfolio knowledge base.
Collaboration & Networking- Build strong relationships with internal stakeholders (production, quality, engineering, finance, procurement).
- Collaborate with external partners, engineering companies, and equipment suppliers to optimize project outcomes.
- Participate in internal and external networks to stay informed about new technologies and industry trends.
Professional Development- Stay updated on pharmaceutical engineering standards, CAPEX project management methodologies, and regulatory evolutions.
- Maintain and develop your project management skills (PMI, PRINCE2, Agile where relevant).
Profile Requirements
Education- Master’s degree in Engineering (Mechanical, Chemical, Industrial, Process, Pharmaceutical Engineering or related field).
- Additional education in project management or business is a plus.
Project Management Certification- Project management certification (PMP, PRINCE2, IPMA or equivalent) is highly valued.
Experience- Minimum 3 years of experience managing CAPEX projects in the pharmaceutical, biotech, or highly regulated life science industry.
- Proven track record delivering medium to large-scale investment projects (e.g., new production lines, cleanrooms, utilities, labs, warehouses).
Technical & Scientific Knowledge- Solid understanding of pharmaceutical processes, clean utilities (WFI, PW, clean steam), HVAC, cleanrooms, and production equipment.
- Familiarity with engineering standards and project phases (URS, basic/detailed design, FAT/SAT, commissioning, qualification).
Regulatory & Quality Knowledge- Strong knowledge of GMP/GxP, FDA/EMA requirements, and relevant industry guidelines.
- Experience working closely with Quality, Validation, and Regulatory Affairs teams.
Leadership & People Skills- Demonstrated ability to lead cross-functional and multicultural teams.
- Strong influencing skills, able to align diverse stakeholders around project objectives.
- Capacity to manage contractors and external engineering partners.
Communication Skills- Excellent written and verbal communication skills.
- Ability to prepare clear presentations and reports for technical and non-technical audiences.
- Proficiency in English and French/Dutch
Analytical & Problem-Solving Skills- Strong analytical mindset, able to challenge technical solutions and cost estimates.
- Ability to anticipate issues, propose pragmatic solutions, and make decisions under time and budget constraints.
Collaboration & Networking- Proven ability to build and maintain effective relationships with internal clients, suppliers, and external partners.
- Comfortable working in a matrix organization and interacting with global teams.
Adaptability & Resilience- Ability to manage multiple projects and priorities in a dynamic environment.
- Resilient, solution-oriented, and comfortable with ambiguity and change.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!