​​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.

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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, 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

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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

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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 thomas.white@mantellassociates.com.