Process Validation Engineer- MSAT

Adryan

Leiden

On-site

EUR 45,000 - 60,000

Full time

14 days+
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Job summary

Adryan, located in The Netherlands, is seeking an Engineer – MSAT Validation for a one-year role with the possibility of extension. This position involves executing and coordinating validation activities in a GMP manufacturing environment.

The ideal candidate should hold a Bachelor's degree in Engineering or related fields and possess at least 2 years of relevant experience. Strong communication, problem-solving, and technical writing skills are also necessary.

Qualifications

  • 2+ years of experience in pharmaceutical, biotech, or biologics manufacturing.
  • Experience with validation, CQV, process validation, or equipment qualification (IQ/OQ/PQ).
  • Strong communication, problem-solving, and technical writing skills.

Responsibilities

  • Execute and coordinate validation activities including cleaning, mixing, sterilization, and hold‑time studies.
  • Author and review validation protocols, reports, and risk assessments.
  • Support process improvements, technology transfers, and new technology implementations.

Skills

Validation
GMP knowledge
Technical writing
Problem-solving
Communication

Education

Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field

Job description

Duration: 1 year with extension possibility

Adryan is an internationally operating services group. From our offices in The Netherlands and Switzerland, we offer a full range of services for the life sciences industry. We are specialised in the areas of project management, engineering, CQV and compliance.

About the role

We are looking for an Engineer – MSAT Validation to support validation and continuous improvement activities within a GMP manufacturing environment.

Key Responsibilities
  • Execute and coordinate validation activities including cleaning, mixing, sterilization, and hold‑time studies.
  • Author and review validation protocols, reports, and risk assessments.
  • Support process improvements, technology transfers, and new technology implementations.
  • Collaborate with Manufacturing, Quality, Engineering, and Project teams.
  • Support investigations, CAPAs, change controls, and inspection readiness activities.
Requirements
  • Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
  • 2+ years of experience in pharmaceutical, biotech, or biologics manufacturing.
  • Experience with validation, CQV, process validation, or equipment qualification (IQ/OQ/PQ).
  • Knowledge of GMP and pharmaceutical regulatory requirements.
  • Strong communication, problem-solving, and technical writing skills.
Preferred Qualifications
  • Experience in MSAT, technology transfer, biologics, vaccines, cell & gene therapy, or sterile manufacturing.
  • Lean/Six Sigma or continuous improvement experience.
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