QA Cleaning Validation Engineer is to assist the QA Validation Coordinator in ensuring the validated status of the manufacturing processes; cleaning, equipment and facility are maintained.
QA Cleaning Validation Engineer- Pharmaceuticals- Dublin
The primary purpose of the QA Cleaning Validation Engineer is to assist the QA Validation Coordinator in ensuring the validated status of the manufacturing processes; cleaning, equipment and facility are maintained. This role will involve generation, execution and close out of validation projects relating to existing products and new product introductions
- Implementation and execution of the cleaning validation program.
- Participating as a project team member for New Product/Process introductions from a validation perspective.
- Implementation and maintenance of the re-validation program.
- Generation and execution of FAT, SAT, IQ, OQ and PQ protocols and reports in compliance with cGMP requirements, FDA and European regulations
- Conducting activities in the following areas as directed by the Validation Co-ordinator: Cleaning Validation, Process Validation, Equipment Validation, Facility & Utility Qualification & Software Validation
- Raising, tracking, and closing out protocol deviations during protocol execution
Education and Experience:
- The successful candidate will have graduated with a minimum of a BSc (life science) or BEng in a relevant discipline and will possess the following Knowledge, Skills and Experiences.
- At least 3 years' experience working within a cGMP pharmaceutical manufacturing environment.
- Prior experience of implementing cleaning validation programmes and handling potent components is important.
- Experience of New Product/Process introductions from a validation perspective.
- Experience of implementing and executing a "re-validation" programme.
- Experience in as many of the following areas of validation as possible; Cleaning Validation, Process Validation, Equipment Validation, Facility & Utility Qualification & Software Validation
- Experience in writing, and executing FAT, SAT, IQ, OQ and PQ protocols and reports. Excellent interpersonal skills and communication skills are essential. The ability to develop effective relationships with staff at all levels across the organisation.
- Excellent report writing and communication skills.
- Excellent organizational and problem solving skills (think outside the box).
- It would be desirable for candidates to have;
- Experience/knowledge of "Risk based approach to validation"
- Experience of working in a cross functional project team.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.