Equipment Validation Engineer
About the Company:
Innopharma Technical Services, part of Innopharma Group, specialise in the provision of highly skilled resources for Life Sciences industries.
Innopharma Technical Services in partnership with our leading Pharmaceutical/ Biopharmaceutical client companies is looking to recruit a CQV Engineer for their Dublin & Limerick site. As part of a significant expansion of our client facility, an exciting opportunity has come to join their Validation team.
Location: Dublin & Limerick
Key Responsibilities:
Responsible for implementing Company qualification program for initial qualification of laboratory and/ or manufacturing equipment, at the site’s bulk biologics facility.
Document preparation:
- Equipment Qualification Assessments (EQAs)
- Installation Qualifications (IQs), Operational Qualifications (OQs), and where applicable Performance Qualifications (PQs).
Summary Reports (SRs), Trace Matrices (TMs):
- Execution for IQ, OQ and where applicable, PQ.
- Maintain progress trackers for document preparation and execution activities.
- Attend daily co-ordination meetings with the Area Lead / QA Validation specialist / Associate Manager.
Preferred Experience:
- Minimum Level 8-degree in science or related.
- Proven experience in QA activities for Equipment Validation within a GMP environment.
- Strong technical writing and documentation skills.
- Experience in Lab Equipment/ System Validation activities.
- Experience with generation, review & approval of IOPQ protocols and associated validation documents.
- Expertise in Supervision on execution activities for Lab systems and related operational software packages.
- Excellent communication and collaboration skills.
- A proactive, detail-focused approach with a passion for continuous improvement.
Note:
•Due to the nature of the business additional duties may be assigned from time to time.
•All applicants must be eligible to work in Ireland.
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If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.
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