Director

Summary:

• The role is responsible for Cleaning Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers.
• This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG).
• BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy, and Medical Devices.
• The Cleaning Validation Engineer will be responsible for the execution of cleaning validation activities to support enzyme manufacturing, generating and executing cycle development, cleaning verification, and cleaning validation documentation including protocols, final reports, deviations, and SOPs while ensuring compliance to GMP requirements.
• Develop and execute cleaning validation protocols to support all required cleaning validation efforts, this will include but is not limited to Clean Hold and Dirty Hold cleaning validation activities.
• Coordinate, schedule and execute all cleaning development, validation and, continuous monitoring/verification activities with appropriate departments.
• Investigate and troubleshoot problems that occur during cleaning processes.
• Lead investigations for deviations encountered during the execution of Cleaning Validation and/or continuous monitoring/verification activities and provide documentation to support the findings.
• Develops and authors change controls for cleaning processes or equipment changes.
• Write validation plans and risk assessments related to specific projects and facilities.
• Perform risk assessment and gap analysis for site cleaning programs.
• Coordinate and provide training and/or opportunities for the career development of others.
• Perform other duties as assigned.
• Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.

Education:

• Bachelor’s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology, or Biomedical Engineering.

Experience:

• Minimum of 1-3 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of two (2) years of direct cleaning validation experience.
• Solid understanding of GMP guidance, including 21 CFR Part 11, and Annex 11.
• Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
• Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control is required.
• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11, etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems in the Biotech and/or Pharmaceutical industry
• Excellent communication and listening skills
• Ability to build and maintain strong collaborative relationships across multiple departments
• Microsoft Office and database management skills
• Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.

Required Skills:

• Experience with biological manufacturing processes.
• Project Management advanced experience.
• Certified Lean Professional or Six Sigma Black Belt