Mantell Associates is partnered with a rapidly growing organisation who is searching for a Senior Cleaning Validation Engineer.
Senior Cleaning Validation Responsibilities:
Prepares validation protocols (IQ/OQ/PQ) and final reports for equipment and processes to assure they are in compliance with Code of federal regulations, (CFR), International Society for Pharmaceuticals Engineering (ISPE), and Aseptic Processing Guidance.
.Will prepare and or review the User Requirement specifications, System Impact assessments, Design Specifications, Enhanced design reviews, and 21 CFR assessments
Will be the validation lead for major site validation projects such as: equipment cleaning, cleanroom qualification, sterilizers, automated filling machines, utilities, WFI, and clean steam, Will participate in Factory Acceptance testing and Site Acceptance testing
Oversees and executes validation and re-validation studies
Develops validation acceptance criteria
Represents validation in agency and customer audits as an SME
Writes and revises, validation master plans and work instructions
Standard Operating Procedures (SOPs)
Senior Cleaning Validation Engineer Requirements:
BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering or other related discipline
5+ years of experience with BS in Pharmaceutical, Biological or Biotech industry; hands-on experience in manufacturing operations or pilot lab / scale-up operations
Excellent verbal and written communication skills
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.