Senior Cleaning Validation Lead - GMP & Compliance

Validation-; Wade Hampton (SC); Presencial; USD 90 000 - 125 000; Tempo integral

Resumo da oferta

Pinnaql is seeking a Cleaning Validation Specialist to support full lifecycle cleaning validation activities at a regulated manufacturing site in Greenville, SC. The role emphasizes technical ownership and hands-on execution, from strategy through final report, while performing sampling aligned with production schedules.

The ideal candidate will independently lead cleaning validation efforts, possess strong GMP knowledge, and have experience with swab and rinse sampling, CIP systems, and Kneat.

Qualificações

• Bachelor’s degree in Engineering, Chemistry, Biology, or related science.
• 5+ years of cleaning validation experience in regulated environments.
• Experience with full lifecycle: strategy, protocol development, execution, reporting.
• Hands-on sampling using swab and rinse.
• Familiar with GMP and FDA/EU guidelines.
• Authorized to work in the United States without visa sponsorship.

Responsabilidades

• Develop cleaning validation strategies, master plans, and validation plans.
• Establish residue acceptance limits (MACO, HBEL/PDE, cleaning agent limits).
• Author cleaning validation protocols and reports.
• Execute cleaning validation protocols (swab, rinse, visual inspection).
• Coordinate sampling and testing with laboratories.
• Lead or support deviation investigations and CAPA.
• Train operators on cleaning procedures and sampling techniques.
• Provide guidance on cleaning processes (CIP/COP, solvents, cleaning agents).
• Collaborate with Quality, Manufacturing, and Laboratory teams for timely execution.

Conhecimentos

Cleaning validation

GMP knowledge

Technical writing

Independent work

Sampling techniques

CAPA investigations

Team collaboration

Formação académica

Bachelor’s degree in Engineering, Chemistry, Biology, or related science

Ferramentas

Kneat

CIP systems

Descrição da oferta de emprego

Pinnaql is seeking a Cleaning Validation Specialist to support full lifecycle cleaning validation activities at a regulated manufacturing site in Greenville, SC. The role emphasizes technical ownership and hands-on execution, from strategy through final report, while performing sampling aligned with production schedules.

The ideal candidate will independently lead cleaning validation efforts, possess strong GMP knowledge, and have experience with swab and rinse sampling, CIP systems, and Kneat.