Validation Engineer

Our client is seeking multiple Validation Engineers to support commissioning, qualification, and validation activities for a new manufacturing facility, including Process validation, cleaning validation and Computer system validation.

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, or a related field.
• 3-7+ years of experience in validation within pharmaceutical, biotechnology, or medical device industries.
• Experience in equipment qualification, process validation, or computer system validation (CSV).
• Knowledge of GMP, FDA regulations, and applicable industry standards.
• Experience preparing and executing IQ, OQ, and PQ protocols.
• Proficiency in validation documentation, risk assessments, deviation investigations, and CAPA.
• Familiarity with change control, SOPs, and quality management systems.
• Strong technical writing, analytical, CAPA, and communication skills.
• The consultant will be responsible for developing and executing qualification protocols, supporting SATs, and performing cleaning validation and CSV activities across a variety of process equipment and manufacturing systems.
• Equipment may include filtration systems, filters, tanks, pumps, chromatography systems, bioreactors, and associated process equipment. Responsibilities will include preparing and executing IQ/OQ/PQ documentation as applicable, supporting equipment readiness and startup, reviewing technical documentation, and ensuring systems meet approved requirements and applicable GMP standards.
• The ideal candidate will have a strong background in equipment qualification and validation within pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience with cleaning validation, computerized system validation, risk assessments, requirements traceability, deviation resolution, and validation documentation is highly desirable.
• The consultant will work closely with engineering, quality, automation, and equipment vendors to resolve deficiencies, maintain compliance, and support the successful startup of manufacturing operations.