1507
Validation Engineer
Cork, Ireland
Engineering
Contract
1507
Posted on:
September 9, 2024
The Highlights:
- Opportunity to work with a world leading pharmaceutical company
- Excellent potential for upward development
- Work with leading edge technology
The Role:
Elusav Recruitment have an excellent opportunity with a leading global Pharma and Biopharma company who is seeking a Validation Engineer to bring value to their premier, state-of-the-art facility in Cork.
The Cork site is excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation.
Job Responsibilities:
- Execute cleaning cycle development, cleaning validation and PQ of equipment.
- Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
- Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
- Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
- Technical report writing, statistical analysis of data
- Adherence to the latest regulatory guidelines.
- Represent the IPT on cross-functional project teams.
- Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
- Adherence to highest standards for Compliance (Quality and Safety)
- Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Job Requirements:
- 3-5 years’ experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
- Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
- A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.
If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on stephen@elusav.com or +3536959993.
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Validation Engineer
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