Job Title: Senior Validation Engineer
Join to apply for the Senior Validation Engineer role at LSC, Life Science Consultants.
Location: Carlow, Ireland
About the Role:
LSC has a great contract opportunity for a Validation Engineer to join a global biopharmaceutical company at a state-of-the-art vaccines and biologics manufacturing facility in Carlow. The facility produces various products across therapeutic areas including oncology, autoimmunity, pneumonia, and infectious diseases.
If you have at least 6 years of experience in the pharmaceutical or biotechnology industry and are seeking your next challenge, this could be the perfect opportunity for you.
Key Responsibilities:
1. Providing technical and validation oversight to process, design, and project delivery teams, and coaching associate personnel within the assigned area.
2. Implementing requirements outlined in the site & project Validation Master Plans.
3. Coordinating engineering sub-teams during Cycle Development & Validation activities.
4. Authoring and reviewing SOPs and technical reports, including PQ protocols.
5. Reviewing and approving commissioning, qualification, and validation protocols executed by vendors and cross-functional groups.
6. Supporting regulatory submissions as required.
7. Owning the Change Management process for equipment qualification/validation up to PQ stage.
Candidate Profile:
* Minimum 6 years of C&Q, QA, QC, or Validation experience in a highly regulated industry.
* At least 2 years of process equipment C&Q, QA, Validation experience on large-scale projects or new facility introductions.
* Experience presenting validation documents to regulatory agencies and defending approaches.
* Subject Matter Expert in Equipment Qualification for cleaning, parts washers, vaporized hydrogen peroxide isolators, utilities, and filling & inspection equipment.
* Working knowledge of ASTM E2500, Eudralex, FDA, and ISPE guidelines.
* Experience liaising with engineering, automation, operations, EHS, and QA departments.
* Prior experience with drug processing equipment, PQ, process performance qualification, batch record reviews, and regulatory inspections.
Additional Notes:
Applicants must be eligible to work in Ireland and hold a Stamp 1G or Stamp 4 visa for this contract role. To apply, please submit your application via this advert or contact Gráinne Hodnett at LSC on 021 4777329 for more information.
Additional Details:
* Seniority Level: Mid-Senior level
* Employment Type: Full-time
* Job Function: Manufacturing
* Industry: Pharmaceutical Manufacturing
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