About Xedev
XEDEV is a dynamic Contract Development & Manufacturing Organization (CDMO) specializing in pharmaceutical formulation, process development, and GMP-compliant clinical manufacturing. We support pharmaceutical and biotech companies worldwide in the development of solid oral dosage forms, from early development through to the production of clinical trial material.
Our core expertise lies in advanced particle engineering technologies such as drying, agglomeration, and coating, with spray drying as our flagship technology. These technologies are embedded in a strong GMP framework, enabling the development, scale-up, and manufacturing of high-quality clinical batches in compliance with regulatory requirements.
As an independent development partner, XEDEV bridges the gap between innovative ideas and robust, GMP-compliant pharmaceutical products. Our integrated approach—combining scientific excellence, process understanding, and hands-on experience in GMP production, validation, and technology transfer—allows us to reliably translate development processes into validated manufacturing operations.
From our modern GMP facility in Zele (Belgium), we continue to grow and strengthen our quality systems. To support our expanding GMP operations and validation activities, we are currently looking for a Validation Engineer to join our team. This position can be filled on a full-time or part-time basis.
Your role as Validation Engineer
As a Validation Engineer at XEDEV, you will be responsible for the full validation lifecycle of systems, equipment, and processes in GMP. You will work closely with multidisciplinary teams and play a key role in ensuring compliance, quality, and operational excellence.
You will work independently on projects, while also collaborating closely with colleagues to ensure validation remains compliant, up to date, and fit for purpose.
Key responsibilities
- Planning, executing, and maintaining validation activities (IQ/OQ/PQ) for equipment (process and analytical equipment), systems, and processes to ensure compliance with cGMP regulations
- Writing, reviewing, and maintaining validation documentation (URS, impact/risk assessments, protocols, reports)
- Perform the qualification tests and supervise qualifications activities performed by external partners
- Register, document and follow-u of deviations during qualification/validation testing and during the systems lifecycle
- Actively following up and maintaining the validation status of systems and processes over time.
- Supporting Computer System Validation (CSV) activities in line with GAMP 5
- Performing risk analyses (e.g. FMEA)
- Support in material qualification for raw materials, excipients, and packaging materials used in manufacturing to ensure that quality, safety, and regulatory standards are met
- Ensuring ongoing compliance with GMP and relevant regulatory guidelines (EMA)
- Supporting audits and inspections
- Working both independently and in close collaboration with, QA, engineers, and project teams
- Planning, executing, and maintaining supplier and material qualification activities
- Monitoring and implementing material changes via change request
Your Profile
- Master’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related field
- 2–3 years of experience in validation within a GMP-regulated environment (experience is a strong plus)
- Good knowledge of GMP and validation principles
- Experience with CSV is an advantage
- Able to work independently, while also functioning well in a team environment
- Structured, quality-minded, and proactive
- Strong communication skills
- Fluent in English and Dutch
Why join us?
At Xedev, you will:
- Work across the full validation lifecycle: from initial set-up to maintaining the continuous validated state of equipment, systems and processes
- Be trusted to work independently, while always being part of a supportive and knowledgeable team
- Contribute to challenging projects in highly regulated industries
- Apply your technical expertise in a pragmatic, hands-on environment where quality and compliance go hand in hand
- Grow professionally through diverse projects, responsibility, and continuous learning
- Enjoy a collaborative company culture with short communication lines and real impact
- Benefit from a competitive salary package and additional benefits
Ready to make an impact?
Send your CV and motivation letter to natascha@xedev.com.