BCF OPEN APPLICATION | Validation/Process Engineer

OPEN APPLICATION | VALIDATION / PROCESS ENGINEER | PHARMACEUTICAL INDUSTRY

Locations: Haarlem, Leiden, Oss, Boxmeer

We are looking for motivated and detail-oriented Validation & Process Engineer to join our Akkodis team to work at one of our GMP-regulated pharmaceutical manufacturing clients. In this role, you will be responsible for ensuring that equipment, utilities, and processes meet strict compliance and performance standards in accordance with regulatory requirements (EU GMP, FDA, ICH, etc.).

You will work cross-functionally with engineering, production, QA, and maintenance teams to support the qualification of equipment, validation of processes, and continuous improvement initiatives.

Key responsibilities

As a Validation & Process Engineer you could/will be responsible for:

• Plan, execute, and document equipment qualification activities (IQ/OQ/PQ) in line with GMP and internal standards.
• Lead or support process validation efforts for new products, scale-ups, or technology transfers.
• Coordinate and execute cleanroom, utility, and facility qualification (e.g., HVAC, WFI, compressed air).
• Collaborate with cross-functional teams to design, review, and optimize manufacturing processes.
• Support change control, risk assessments, deviation investigations, and CAPA related to equipment and processes.
• Write, review, and maintain validation protocols, reports, and standard operating procedures (SOPs).
• Participate in audits and inspections; provide technical expertise and documentation as required.
• Ensure data integrity and compliance throughout the validation lifecycle.

Company Details

What about Akkodis?

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have +/- 60 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! 

Candidate Profile

What you bring

• A Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related field.
• Minimum of 2–5 years of experience in equipment validation, process engineering, or commissioning & qualification in a GMP-regulated environment.
• Strong understanding of GMP, GEP, and validation lifecycle principles (V-model, ASTM E2500, ICH Q8/Q9/Q10).
• Experience with cleanroom equipment, aseptic processes, or biotech manufacturing is a strong asset.
• Good communication skills in English; ability to write clear, compliant technical documentation.
• Strong problem-solving skills and attention to detail.

It is a big plus if you have also have:

• Experience with CSV (Computerized System Validation) or automation systems.
• Familiarity with LEAN principles or continuous improvement methodologies.
• Previous involvement in regulatory inspections (e.g., EMA, FDA).

Are you interested in this challenge, or do you want to come in touch?

Please contact your Talent Acquisition Specialist of Akkodis by sending your CV or apply via the button on this page.