QC Lab Instrument Validation Specialist
|Contact Name:||Larry O’Leary|
Our client, an established consulting organization who provides focused support in Pharmaceutical, Biotechnology and Medical Devices industries, now seeks QC Lab Instrument Validation Specialist / Engineer.
The successful candidates will work within an existing integrated project team who are responsible for the qualification of new instrumentation within the QC laboratories in greater Dublin area.
The successful candidate will be responsible for generate and execute documentation for cGMP validation of systems, equipment & manufacturing processes, including validation plans, protocols and reports.
Excellent opportunities currently exist for professionals at all levels with the right blend of skills and experience in process and technology related regulated industries.
This role will suit experienced pharma / biotech professionals who are highly motivated with a clear desire for career development and progression.
Opportunities exist for full-time permanent (with benefits) employees and contractor staff in the greater Dublin area.
Responsibilities of QC Lab Instrument Validation Specialist:
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
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
Requirements for QC Lab Instrument Validation Specialist:
B.Sc. degree qualifications in science, engineering, quality, technical or other related life sciences or engineering discipline.
3+ year validation or qualification experience with laboratory instrumentation, validation and project life cycle, ideally with pharma/biopharma FDA regulated environment.
Proven experience in updating documentation and reports.
Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.
Excellent communication skills and the ability to be analytical.
Please contact Larry on 01-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie