Lead Cleaning Validation Specialist – Full Lifecycle, GMP

Validation & Engineering Group, Inc.; Greenville (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

Pinnaql, a trusted life sciences consulting partner, seeks a Cleaning Validation Specialist for an on-site role at a regulated manufacturing site in Greenville, SC. The candidate will lead validation strategy, execution, and reporting, while performing sampling aligned with production schedules.

The role requires a Bachelor's in a related science and 5+ years of cleaning validation experience, with strong GMP knowledge and hands-on experience in swab and rinse methods.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, or related science.
• 5+ years of cleaning validation experience in a regulated environment (pharmaceutical, biotech, or medical device).
• Experience with full cleaning validation lifecycle: strategy, protocol development, execution, reporting.
• Hands-on experience with swab and rinse sampling techniques.
• Strong knowledge of GMP requirements and applicable guidance (FDA, EU Annex 15, ICH Q7 and Q9).
• Excellent technical writing skills and ability to work independently.

Responsibilities

• Develop cleaning validation strategies, master plans, and validation plans.
• Establish residue acceptance limits (MACO, HBEL/PDE).
• Author cleaning validation protocols, reports, and risk assessments.
• Execute cleaning validation protocols (swab, rinse, visual inspection).
• Coordinate sampling and testing with laboratories.
• Lead or support deviation investigations and CAPA related to cleaning validation.
• Train staff on cleaning procedures and sampling techniques.
• Provide guidance on cleaning processes, CIP/COP, and manual cleaning.

Skills

GMP knowledge

Technical writing

Independent worker

Experience with sterile manufacturing

Swab/Rinse sampling

Education

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

Tools

Kneat electronic validation

Job description

Pinnaql, a trusted life sciences consulting partner, seeks a Cleaning Validation Specialist for an on-site role at a regulated manufacturing site in Greenville, SC. The candidate will lead validation strategy, execution, and reporting, while performing sampling aligned with production schedules.

The role requires a Bachelor's in a related science and 5+ years of cleaning validation experience, with strong GMP knowledge and hands-on experience in swab and rinse methods.