QA Engineer

Orion Group Life Sciences are currently recruiting QA Engineer on behalf of our Multinational Pharmaceutical client based in Limerick on an initial 8-month contract (with potential to extend).

The client is developing design for a biotech manufacturing facility with an overall floor area of 47,384m2 in Limerick.

This design includes bioprocessing upstream and downstream as well as associated support areas and utilities. This facility will take advantage of single use systems to deliver a state-of-the-art facility incorporating new technologies to support the client's rapidly expanding monoclonal portfolio with a specific focus on operational flexibility, environmental sustainability and fast-track delivery concepts.

The facility will include a 4-storey Biopharmaceutical Manufacturing building approx. 18,534m2 and 33 metres high with roof-mounted plant/equipment & solar panels. A 2-storey canteen, laboratory, and administration building. A 2-storey Warehouse building. A single storey Central Utilities Plant (CUP) building including 5 Boiler stacks. A 2-storey freezer building and a single storey maintenance building.

The project is currently in Detailed Design phase and is on schedule to be in that phase throughout 2022. Commissioning and Qualification of some of the facility will initiate mid to late 2023 and finish at the end of 2024.

Key Responsibilities:

• Quality oversight of and guidance for on capital projects
• Maintenance of all aspects of GMP compliance for the area(s) of responsibility
• Establishment, maintenance, and management of a control system for the specific Quality System(s)/Program
• Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program
• Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program
• Review and approval of change controls and failure investigations, associated with the area(s) of responsibility
• Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
• Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.
• Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, process flow diagrams as appropriate to area of responsibility
• Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility
• Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.

Education:

• BSc, MSc, in Chemistry, Engineering or related discipline.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.