Validation Specialist

Key Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ, process validation, cleaning validation)

• Author validation final reports and ensure timely completion

• Lead validation risk assessments and ensure compliance with GMP/GAMP requirements

• Investigate deviations and support CAPA implementation

• Coordinate with cross‑functional teams (QA, Engineering, Manufacturing)

• Maintain and update Validation Master Plans (VMP)

Qualifications & Experience

• Degree in Engineering, Life Sciences, Biotechnology, or related field

• 4 – 8 years of validation experience in pharmaceutical or biotech manufacturing

• Strong knowledge of GMP, GAMP, and ICH guidelines

• Excellent documentation, communication, and problem-solving skills