Lead Cleaning Validation Specialist

Pinnaql, Inc.; Greenville (SC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Job summary

Pinnaql, Inc. is looking for a Cleaning Validation Specialist to support full lifecycle validation at a regulated site in Greenville, SC. The role combines strategy development with hands-on sampling and execution to ensure compliance with GMP and regulatory standards.

The candidate will lead validation planning, execute protocols, and collaborate with Quality, Manufacturing, and Laboratory teams, while training staff and guiding CAPA efforts as needed.

Qualifications

• Bachelor’s degree in Engineering, Chemistry or Biology.
• 5+ years of cleaning validation in a regulated environment.
• Experience across strategy, protocol development, execution and reporting.
• Hands-on swab and rinse sampling experience.
• GMP knowledge: FDA, EU Annex 15, ICH Q7/Q9.
• Excellent technical writing; able to work independently.
• Experience in sterile or ophthalmic manufacturing.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Develop cleaning validation strategies, master plans and validation plans.
• Establish residue acceptance limits (MACO/HBEL/PDE).
• 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.
• Provide technical guidance on CIP/COP and cleaning methods.
• Collaborate with Quality, Manufacturing and Laboratory teams.
• Support other commissioning, qualification and validation activities.

Skills

Cleaning validation

GMP compliance

Sampling techniques

Technical writing

Independent work

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Chemistry

Bachelor’s degree in Biology

Tools

Kneat

Job description

Pinnaql, Inc. is looking for a Cleaning Validation Specialist to support full lifecycle validation at a regulated site in Greenville, SC. The role combines strategy development with hands-on sampling and execution to ensure compliance with GMP and regulatory standards.

The candidate will lead validation planning, execute protocols, and collaborate with Quality, Manufacturing, and Laboratory teams, while training staff and guiding CAPA efforts as needed.