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
- 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: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)