Role: Gx P Validation Engineer
Location:
Poland
Experience:
6–8 Years
Domain:
Life Sciences – Computer System Validation
We are seeking a skilled
Gx P Validation Engineer
to ensure compliance of digital systems within Clinical, Regulatory Affairs, Medical Affairs, and Pharmacovigilance (PV) functions. The ideal candidate will develop and execute validation protocols, conduct risk assessments, and maintain comprehensive documentation supporting audit readiness and regulatory compliance.
Key Responsibilities
Develop, review, and execute validation protocols ( IQ, OQ, PQ ) in alignment with project and regulatory requirements.
Conduct and document
risk assessments , deviations, and change controls for validated systems.
Ensure systems comply with
Gx P, 21 CFR Part 11, EMA Annex 11 , and related global regulatory guidelines.
Maintain detailed
validation documentation
and ensure audit readiness.
Collaborate effectively with cross‑functional and cross‑geography teams to support project delivery and system lifecycle activities.
Strong knowledge of
Computer System Validation (CSV)
processes and GAMP 5 principles.
In-depth understanding of
Gx P, 21 CFR Part 11, EMA Annex 11
compliance requirements.
Familiarity with systems used in Clinical, Regulatory, Medical Affairs, and PV Safety domains.
Excellent
communication and interpersonal skills.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
