Cleaning Validation Specialist Position Available In Wake, North Carolina

Cleaning Validation Specialist AR Validation Services LLC Holly Springs, NC Job Details Estimated:

$83.5K – $115K a year 1 day ago Qualifications CGMP 7 years ICH Q7 Mid-level ICH Q9 Master’s degree Bachelor’s degree

HACCP ICH Q10

Cleaning APIs Chemistry FDA regulations

Full Job Description Position Summary:

The Cleaning Validation Specialist is responsible for planning, executing, and documenting cleaning validation activities for pharmaceutical manufacturing equipment and systems. This role ensures that cleaning processes comply with regulatory standards (FDA, EU, ICH) and internal quality requirements to prevent cross-contamination and ensure product safety.

Key Responsibilities:

Develop and execute cleaning validation protocols (IQ, OQ, PQ) and final reports. Conduct risk assessments and worst-case product selection for cleaning validation. Design cleaning validation strategies and sampling plans (swab and rinse). Coordinate and perform cleaning validation activities across manufacturing equipment (e.g., tanks, mixers, blenders, reactors, filling lines). Ensure compliance with current Good Manufacturing Practices (cGMP), FDA, and EU regulations. Work cross-functionally with Manufacturing, Quality Assurance, Engineering, and R D teams. Investigate and troubleshoot cleaning validation failures and deviations. Maintain and update cleaning validation master plans and SOPs. Participate in regulatory inspections and audits as SME for cleaning validation. Review and approve cleaning validation documentation, change controls, and risk assessments.

Required Qualifications:

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, or related field. 3 7 years of experience in cleaning validation within a regulated pharmaceutical or biopharmaceutical environment. Strong knowledge of c

GMP, FDA, ICH Q7/Q8/Q9/Q10

guidelines, and Annex 15. Experience with cleaning agents, residue limits, and analytical methods (TOC, HPLC, UV, etc.). Proficient in writing protocols, reports, and technical documents. Familiarity with risk management tools (FMEA, HACCP, etc.) is preferred.

Preferred Skills:

Experience with CIP (Clean-in-Place) and COP (Clean-out-of-Place) systems. Experience in API, OSD, Sterile, or Biologics manufacturing environments. Familiarity with validation lifecycle and computerized systems (e.g., TrackWise, Veeva).