Senior Project Manager - Greenfield Fill & Finish Project

Help Shape the Future of Prothya Biosolutions

Find out more about this role by reading the information below, then apply to be considered.

Prothya Biosolutions Belgium is entering an exciting phase of growth and transformation. As part of the Intas Group, we continue to invest in our people, infrastructure and manufacturing capabilities to support our long-term strategic ambitions.
To support this growth, we are launching a major investment project: the development of a new GMP-compliant Fill & Finish manufacturing facility at our Brussels site.

To lead this ambitious program, we are looking for an experienced

Senior Project Manager

with a proven track record in delivering large-scale pharmaceutical capital projects. This is a unique opportunity to take full ownership of a strategically important greenfield project that will play a key role in the future of Prothya's manufacturing network.

Your Mission
As Senior Project Manager, you will be responsible for the successful delivery of the Fill & Finish Greenfield Project from concept through operational handover. You will lead all stages of the project lifecycle, including design, permitting, procurement, construction, commissioning, qualification, validation and start-up.
Working closely with site leadership, corporate stakeholders, engineering partners, contractors, equipment suppliers and regulatory authorities, you will ensure the project is delivered safely, compliantly, on schedule and within budget.
This role requires an experienced leader who can combine pharmaceutical expertise, technical knowledge and strong project governance to successfully manage a highly complex investment program.

Key Responsibilities
Project Leadership & Governance
Lead the project from initial concept through final handover and project closure.
Establish and maintain the overall project strategy, governance structure, master schedule and execution plan.
Define clear project objectives, responsibilities, interfaces and decision-making processes.
Drive timely decisions and proactively manage risks, issues and project dependencies.
Ensure project delivery within approved scope, budget and timeline.
Engineering & Facility Design
Coordinate concept design, basic engineering and detailed engineering activities.
Ensure facility design meets GMP, operational, quality, safety and business requirements.
Oversee multidisciplinary engineering activities including cleanrooms, HVAC, utilities, automation, process equipment, logistics and building infrastructure.
Manage design reviews, risk assessments and value engineering exercises.
Ensure integration between facility design, manufacturing processes and operational needs.
Permitting & Regulatory Compliance
Develop and execute the project permitting strategy.
Coordinate environmental, urban planning and construction permit activities.
Engage with relevant authorities and ensure compliance with Belgian regulatory requirements.
Identify and mitigate permitting and regulatory risks.
Align project execution with GMP requirements and intended manufacturing activities.
Procurement & Contract Management
Develop the procurement and contracting strategy together with internal stakeholders.
Lead tendering, supplier selection and contract negotiations.
Manage engineering firms, construction contractors, equipment suppliers and project partners.
Ensure clear scopes of work, technical specifications and contractual responsibilities.
Monitor supplier performance, costs, deliverables and project risks.
Construction & Execution
Lead construction, installation and site execution activities.
Coordinate contractors and ensure compliance with approved designs and safety standards.
Manage interfaces between construction activities and ongoing site operations.
Monitor project progress and implement recovery plans when required.
Ensure quality standards and inspection requirements are consistently met.
Commissioning, Qualification & Validation
Integrate CQV requirements from the earliest project phases.
Develop and execute commissioning and qualification strategies.
Coordinate start-up, validation and GMP readiness activities.
Ensure operational readiness, documentation, training and maintenance preparation.
Lead the transition from project execution to operational ownership.
Budget, Risk & Project Controls
Maintain full ownership of project controls, budget and financial performance.
Manage forecasting, cost control, change management and risk mitigation.
Develop and maintain project schedules, risk registers and reporting packages.
Present project updates, risks and recommendations to senior leadership and steering committees.

What We're Looking For

Essential Qualifications & Experience
Master's degree in Engineering or equivalent through experience.
Minimum 15 years of project management experience within the pharmaceutical industry.
Proven success delivering major pharmaceutical CAPEX projects exceeding €60 million.
Extensive experience across the full project lifecycle, including design, construction, commissioning and operational handover.
Strong knowledge of GMP-regulated manufacturing environments.
Experience managing multidisciplinary teams, contractors and international stakeholders.
Thorough understanding of project controls, budgeting, procurement, risk management and contract management.
Excellent leadership, communication and stakeholder management skills.
Fluent in English.

Strongly Preferred
Direct experience delivering pharmaceutical Fill & Finish projects.
Experience with aseptic manufacturing and sterile processing environments.
Knowledge of cleanroom design, contamination control and sterile manufacturing requirements.
Experience integrating filling and packaging equipment into GMP facilities.
Practical understanding of qualification, validation and GMP start-up activities.
Direct experience with in interacting with relevant authorities and ensure compliance with Belgian regulatory requirements.

Why Join Prothya?
At Prothya, we combine the ambitions of a growing international organization with the accessibility and collaborative culture of a company where people know each other by name.
This is a rare opportunity to lead a major strategic investment with significant visibility and long-term impact on our organization.

We offer:
A unique opportunity to lead a high-profile pharmaceutical greenfield project from A to Z.
Direct exposure to local and international leadership teams.
A dynamic and collaborative environment within the Intas Group.
Competitive salary and comprehensive benefits package.
Company car, energy card, health and group insurance.
Meal vouchers, net allowance and Flex Reward Plan. xlxgzvr
Attractive holiday arrangements and hybrid working opportunities.

Location:

Neder-Over-Heembeek, Brussels, Belgium

If you are an experienced pharmaceutical project leader ready to shape the future of Prothya Biosolutions, we would love to hear from you.