What are the responsibilities and job description for the Cleaning Validation Engineer position at QvalFocus Inc.?
Location: Boulder,CO
Location Type: Hybrid
Duration: 6 12 Months (Contract)
Job Description
We are seeking an experienced Cleaning Validation Engineer to support pharmaceutical and biotechnology manufacturing projects. The ideal candidate will have hands-on experience in cleaning validation for GMP-regulated environments and a strong understanding of FDA, EU GMP, and industry guidance. This role will be responsible for developing, executing, and documenting cleaning validation activities to ensure manufacturing equipment and processes meet regulatory compliance requirements. Compli provides cleaning validation support as part of its broader CQV and regulatory consulting services.
Responsibilities
Location Type: Hybrid
Duration: 6 12 Months (Contract)
Job Description
We are seeking an experienced Cleaning Validation Engineer to support pharmaceutical and biotechnology manufacturing projects. The ideal candidate will have hands-on experience in cleaning validation for GMP-regulated environments and a strong understanding of FDA, EU GMP, and industry guidance. This role will be responsible for developing, executing, and documenting cleaning validation activities to ensure manufacturing equipment and processes meet regulatory compliance requirements. Compli provides cleaning validation support as part of its broader CQV and regulatory consulting services.
Responsibilities
- Develop, execute, and review Cleaning Validation protocols and reports.
- Perform equipment cleaning validation for manufacturing and process equipment.
- Conduct risk assessments and establish scientifically justified cleaning acceptance limits (MACO/PDE).
- Support Clean-In-Place (CIP) and Steam-In-Place (SIP) validation activities.
- Execute sampling activities including swab and rinse sampling.
- Investigate deviations, out-of-specification results, and implement CAPA.
- Support change controls, revalidation activities, and periodic reviews.
- Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams.
- Ensure compliance with FDA, EU GMP, ICH, and company quality standards.
- Participate in internal and regulatory inspections and provide validation support.
- Maintain validation documentation in accordance with ALCOA and Good Documentation Practices (GDP).
- Bachelor's degree in Chemical Engineering, Biotechnology, Pharmacy, Chemistry, or a related Life Sciences field.
- 4 8 years of Cleaning Validation experience in pharmaceutical, biotechnology, or medical device manufacturing.
- Experience preparing and executing Cleaning Validation protocols and reports.
- Knowledge of FDA 21 CFR Parts 210/211, EU GMP Annex 15, ICH guidelines, and cGMP regulations.
- Experience with CIP/SIP systems and cleaning process validation.
- Understanding of MACO calculations, PDE limits, and risk-based validation approaches.
- Experience with deviation investigations, CAPA, and change control.
- Strong technical writing and documentation skills.
- Excellent communication and cross-functional collaboration skills.
- Experience with sterile or aseptic manufacturing environments.
- Experience supporting CQV projects.
- Familiarity with Validation Master Plans (VMPs), SOPs, and lifecycle validation.
- Experience supporting FDA, MHRA, EMA, or other regulatory inspections.