- Cleaning Validation Specialist
Description:We are seeking a
Cleaning Validation Specialist to support full lifecycle cleaning validation activities at a regulated manufacturing site in Greenville, SC. This role is part of a broader initiative to strengthen cleaning validation practices and ensure compliance with current regulatory and site standards.
The position requires both technical ownership and hands on execution. The ideal candidate can independently lead cleaning validation efforts, from strategy through final report, while also performing sampling and execution activities in alignment with production schedules.
Key Responsibilities:- Develop cleaning validation strategies, master plans, and validation plans, including product and equipment grouping and worst case selection
- Establish or support residue acceptance limits (MACO, HBEL/PDE, and cleaning agent limits)
- Author cleaning validation protocols, reports, and supporting risk assessments
- Execute cleaning validation protocols, including swab, rinse, and visual inspection
- Coordinate sampling and testing activities with the laboratories
- Lead or support deviation investigations, root cause analysis, and CAPA related to cleaning validation
- Train operators and staff on cleaning procedures, sampling techniques, and protocol execution
- Provide technical guidance on cleaning processes, including cleaning agents, solvents, CIP and COP, and manual cleaning methods
- Collaborate with Quality, Manufacturing, and Laboratory teams to ensure successful and timely execution
- Support other Commissioning, Qualification, and Validation activities as needed based on project demands
Required Qualifications:- Bachelor's degree in Engineering, Chemistry, Biology, or a related science
- 5+ years of cleaning validation experience in a regulated environment (pharmaceutical, biotech, or medical device)
- Proven experience with the full cleaning validation lifecycle: strategy, protocol development, execution, and 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
- Ability to work independently with minimal supervision
- Experience in sterile or ophthalmic manufacturing
- Experience with CIP systems and automated cleaning processes
- Experience with electronic validation systems (for example, Kneat)
- Candidates must be authorized to work for any employer in the United States without visa sponsorship, we are not able to sponsor a visa or work on a C2C basis for this opportunity.
Work Requirements:- On site position in a manufacturing environment
- Flexibility to work early, late, off shift, and weekend hours to support sampling based on production schedules
- Ability and willingness to enter confined spaces, including tanks and similar equipment, to perform inspections, measurements, and sampling in compliance with site safety procedures
