JOB TITLE: QC Lab Instrument Validation Specialist/Engineer
INDUSTRY: Biotechnology / Pharmaceutical
LOCATION: Dublin / Kildare
ABSOLUTE TECHNICAL SOLUTIONS (ATS) is an established technical & consultant organisation working throughout Ireland and the UK in the areas of project/commissioning management, technical support and compliance services. The company provides focused support in process and technology related regulated industries including Pharmaceutical, Biotechnology and Medical Devices.
Due to increasing opportunities we are recruiting both full time staff and contract personnel to join our organisation based out of Northern Ireland and Dublin regions. Excellent opportunities currently exist for personnel at all levels with the right blend of skills and experience.
ROLE DESCRIPTION & KEY RESPONSIBILITIES:
- The successful candidates will work within an existing integrated project team who are responsible for the qualification of new instrumentation within the QC laboratories.
- Preparation/Review of project deliverables across the full project lifecycle including:-
- User Requirements Specifications
- Design Review
- Instrumentation Doc Packs
- Traceability Matrices
- Validation Test Protocols
- Handover and summary reports.
- Ensure compliance with cGMP and data integrity regulatory requirements.
- Co-ordination and Execution of Validation protocols.
- Work closely with the instrumentation suppliers including the scheduling of installation and technical support.
- Setup of the preventative maintenance and calibration schedules for new instrumentation.
- Assist in the training of laboratory analysts to increase their knowledge on the new analytical instrumentation.
- Degree qualification - science, quality, technical or other related discipline
- Excellent communication skills and the ability to be analytical.
- Highly motivated with a clear desire for career development and progression
- 2 to 5 years experience and knowledge in the areas of laboratory instrumentation, validation and project life cycle.
- Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.
Please submit current CV with detailed covering letter outlining relevant experience or interest in the role.
Competitive Salary - Negotiable