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Manufacturing & Production

Scientific & Laboratory

Job Description

A Validation Manager required by CareerWise Recruitment for our Mayo based client. If you have People Management & Biologics experience then this is the job for you !!!

Role of this position

  • Responsible for the coordination of all Validation activities at the Mayo site.
  • Site Subject Matter Expert for the validation function
  • Manage the Validations Team on a day-to-day basis, identify training requirements and develop the skillset within the group to support operations relating to validation.
  • Develop individual goals and objectives for validation team members to support personal and company goals.
  • Represent the Validations Department in regulatory (FDA/HPRA) and client audits as required.
  • Ensure adherence to the site Validation Master Plan in all activities performed by the Validation Department.
  • Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).
  • Supporting the Validations team in completing any deviations/out of limits encountered during validation projects and implementing effective CAPA actions.
  • Coordination of on-site Validation Contractor Activities to ensure adherence to EH&S and Quality systems requirements.
  • Work closely with other Departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
  • Technical review and approval of Validation documents submitted by the validations team or external vendors.
  • Be a team member for Capital projects involving Validation deliverables identified by site management.
  • Maintenance of key site Validation documents to include Validation Master Plan, Equipment and Process Validation Master Plan, Validation Department SOP's, Site Re-Qualification Schedule.
  • Ensuring that all site validation equipment (Data Loggers, Hot Blocks, Pressure Transducers etc) are regularly calibrated and certified for use.
  • Coordinate and communicate the Validation schedule to site management on a regular basis.

JOB REQUIREMENTS

  • Bachelor's degree in Science, Engineering, Technology or a related discipline
  • Minimum of 3 years' experience as a validation engineer/specialist in a cGMP environment preferably in the Medical Device/Pharma Industry.
  • Proven track record of managing people

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Manufacturing & Production

Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie