Process Engineer - Pharma

Are you an experienced Process Engineer with a strong background in the pharmaceutical or biotech industry? Do you enjoy translating complex process, quality and regulatory requirements into efficient, safe and compliant technical solutions?

For our Process team, we are looking for a Process Engineer – Pharma to strengthen our team in Belgium (Tienen and Beringen).

As a Process Engineer at Polytek, you are responsible for designing, optimising and safeguarding industrial processes for pharmaceutical and biotech clients. You ensure that process solutions are efficient, safe, compliant and cost-effective.

You act as the process point of contact on complex and multidisciplinary projects, translating client, regulatory and quality requirements into robust process designs. At the same time, you use your experience to guide junior engineers and help the team deliver to high technical and quality standards.

The role combines hands-on process engineering with multidisciplinary coordination, technical leadership and client interaction.

What you will do:

• Analyse stakeholder and client requirements and translate them into technical process solutions.

• Participate in internal and external project kick-off meetings and ensure all necessary technical information is available to the project team.

• Design and optimise industrial pharmaceutical processes with a strong focus on efficiency, safety, quality and regulatory compliance.

• Translate project requirements and applicable pharmaceutical regulations and standards into practical process designs.

• Safeguard cGMP principles throughout the process design.

• Take into account requirements related to cleanroom classification, containment, cleaning and pharmaceutical utilities, including WFI, purified water and clean steam.

• Support the qualification and validation strategy (IQ/OQ/PQ) in collaboration with QA.

• Prepare and review process calculations in line with the relevant project phase and applicable international and pharmaceutical industry standards.

• Communicate with suppliers and equipment vendors and review relevant technical and qualification documentation.

• Create, review and finalise technical deliverables according to the project's delivery requirements.

• Coordinate with other technical disciplines and ensure that process solutions are properly integrated into the overall project.

• Provide technical input to BIM Modelers and review and follow up on their work.

• Coach and mentor Process Engineers, reviewing their technical output and supporting their development.

• Act as a technical point of contact for key pharmaceutical clients.

• Identify opportunities with existing and new clients and provide technical input for proposals and tenders.

Who you are:

• You have a Master's degree in (Bio)Chemical, Process, Pharmaceutical or Industrial Engineering, or an equivalent qualification.

• You have at least 8–10 years of relevant process engineering experience.

• You have a proven track record within the pharmaceutical and/or biotech industry.

• You have experience working in a senior or lead engineering capacity.

• You have in-depth knowledge of cGMP and pharmaceutical regulatory requirements and standards, including EU GMP, FDA 21 CFR Parts 210/211 and Part 11, ICH Q7/Q8/Q9, ISPE Baseline Guides and GAMP 5.

• You are familiar with the qualification and validation lifecycle (IQ/OQ/PQ) and cleanroom classification according to ISO 14644-1.

• You have experience with MS 365 and process simulation/calculation tools, such as FluidFlow.

• You have a good command of English and Dutch; other languages are a plus.

• You are proactive and take initiative, identifying technical challenges and opportunities before they become issues.

• You enjoy coaching and supporting less experienced engineers and helping them develop their technical expertise.

• You are comfortable building and maintaining professional relationships with clients, suppliers and other stakeholders.

• You demonstrate integrity and handle confidential or sensitive information professionally.

• Working Together: you collaborate naturally with colleagues, clients and other engineering disciplines to achieve a shared result.

• Sharing Knowledge: you actively share your expertise, experience and best practices and contribute to the continuous development of the team.

• Customer Orientation: you understand the needs and expectations of pharmaceutical clients and translate them into high-quality technical solutions.

Ready to join our team?

Are you ready to use your process engineering expertise and pharmaceutical industry experience to develop safe, efficient and compliant solutions for challenging pharma and biotech projects?

Do you recognise yourself in our values of Working Together, Sharing Knowledge and Customer Orientation?

Then we'd love to hear from you. Apply now and join our team in Tienen or Beringen

About us

• Polytek was founded on a clear and non-negotiable principle: getting it right from the start. As engineers and builders, we’ve seen how industrial projects are too often mismanaged. 

• With an advanced 3D modelling process, rigorous preparation, and extensive on-site experience, Polytek can map out industrial projects in such detail that we can confidently deliver on time and within budget. 

• To steer industrial projects effectively and efficiently, we collaborate with all stakeholders and work our way through a four-step process. First, we initiate. Next we design, then we build, and finally, we operate. Always with the utmost attention to detail. 

• By uniting different perspectives and skill sets, we can tackle challenges from all angles: engineering, project management, architecture, process development and innovation. 

• Yes indeed, the ‘poly’ in our name is not just a play on words. It’s a reflection of who we are and what we’re capable of.