Senior Validation Engineer GMP

Do you want to work in the biotechnology sector and focus on advanced therapies for patients with serious diseases? We are hiring for an organization that works with cutting‑edge technologies in a highly regulated (GMP) environment. To support ongoing growth and innovation, they we looking for an experienced professional in validation and qualification.

Job Description
As a Validation & Qualification Specialist, you will be responsible for planning, executing, and documenting validation activities for equipment, facilities, and computerized systems. You work closely with engineering, manufacturing, quality teams, and external suppliers to ensure systems meet GMP and GxP requirements. The role involves supporting projects from design through implementation, maintaining validated states, and contributing to change management, risk assessments, and deviation investigations.

Responsibilities

Prepare, review, and approve validation and qualification documentation.

Execute and support IQ, OQ, and PQ activities, including deviation handling.

Develop validation plans and summary reports for projects.

Collaborate with cross‑functional teams and external vendors.

Review impact assessments, risk analyses, and change requests.

Support lifecycle management and periodic review of validated systems.

Contribute to root cause investigations and CAPA activities.

Requirements

Bachelor's or Master's degree in Engineering, Life Sciences, or a related discipline.

At least 5 years of experience in commissioning, qualification, and validation within a GMP environment.

Proven experience validating equipment, utilities, facilities, and computerized systems.

Strong knowledge of GMP/GxP and risk‑based validation approaches.

Familiarity with regulatory expectations from authorities such as FDA and EMA.

Strong analytical skills with high attention to detail.

Able to work independently while collaborating effectively with multidisciplinary teams.

Benefits

Temporary contract trough Oxford Global Resources till December 2026

Estimated salary: €6900 gross per month

Region:
Amsterdam area

Working hours:

Monday to Friday, standard office hours (09:00-17:00)

Additional benefits:
Opportunities for development, multidisciplinary collaborations, working with innovative technologies

Vacancy number: 27207

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