Make direct contact with Employer details below.

Job Description:

This is an exciting opportunity for an experienced QA Validation Engineer to join a new startup Bio Logics Company based in Limerick. You could join a well-established US multinational company in their new state of the art facility.

Job Salary: Negotiable.

Job Main duties and responsibilities:

Review / Approval of Validation Protocols (e.g. URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.

Review / Approval of Validation Reports to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.

Resolve and assist in the closure of discepancies initiated during Qualification execution.

Job Key skills and competencies required:

Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.

Ability to develop and give presentations on technical and regulatory topics.

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Education and experience:

Minimum of degree qualification in relevant science and/or engineering discipline.

3 years minimum post-educational experience with working in a regulated environment, preferably within a Pharma/Biotech facility.

4-6 years in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations.

If you’re interested in this great role, please contact Eoin Coffey on 061 208652 or email eoin.coffey@cpl.ie for more details. All communications will be treated with strict confidence.