Equipment Validation Engineer

About the Company:

Innopharma Technical Services, part of Innopharma Group, specializes in the training and employment of highly skilled, project ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

Are you ready to take the next step in your career within a leading biopharma environment?

We are now seeking an Equipment Validation Engineer to join our team to provide Validation support in Lab Equipment/ System Validation activities across the site, in our Multinational Manufacturing client based in Co. Limerick.

Location: Limerick

About the position:

As an Equipment Validation Engineer, you will be involved in Generation/Review & Approval of Validation documents (IOPQ protocols) and providing supervision on execution activities for Lab systems and related operational software packages for IT Infrastructure / Auto/ IT/ Lab/ Enterprise projects, currently being introduced onsite.

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.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.

Apply Now