Senior Cleaning Validation Engineer - Small Molecule

Posted 27 April 2023
Salary Competitive
LocationNorth America
Job type Full Time
DisciplineSmall Molecule
Contact NameThomas White

Job description

Mantell Associates is currently partnered with one of the most upcoming organisations that is expanding and on the search for a Senior Cleaning Validation Engineer to join their team.


  • 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, work instructions, andStandard Operating Procedures (SOPs)

  • Recommends validation procedural and test improvements

  • Maintain current validation project schedules

  • Provide training for both team validation members and contract validation personnel

  • Review critical equipment drawings from a Validation perspective

  • Review and summarize equipment history files to assess the validated state of equipment

  • Proactively identifies potential obstacles to successful project completion

  • Establishes remediation plans to overcome these obstacles; and Participates as validation representative on failure investigation teams


  • 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 Thomas White at +44 (0)20 3854 7718 or