See All Jobs

Engineering & Technical

Job Description

COMMISSIONING & QUALIFICATION ENGINEER required by CareerWise Recruitment for our Gene Therapy client at their start-up facility in Co. Clare. The COMMISSIONING & QUALIFICATION ENGINEE is required to assist the Head of Engineering with the implementation and operation of the site commissioning plan.

Role of this position

  • Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning and Qualification protocols
  • Lead Risk assessments for process and equipment as required
  • Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems
  • Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing CQ carried out by vendors
  • Develop protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices
  • Review and approve Layout development and review for material and personnel flow compliance
  • Review analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data
  • Investigate deviations, write investigation reports and create summary reports
  • Promote cGMP and regulatory compliance into assigned projects
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Strong trouble shooting and Safety compliance experience is essential for this role

JOB REQUIREMENTS

  • BSc/MSc or BEng/MEng in Engineering or related discipline
  • 5 -7 years minimum in validation, quality systems, operations, engineering or any combination thereof
  • Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge
  • Validation experience using risk-based approach guidelines, international regulatory requirements and standards
  • Experience interacting with or creating material for representatives of regulatory agencies and executive level staff
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@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.

Apply Now

Engineering & Technical

Cork Office

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

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie