Calibration Engineer, Subject Matter Expert
|Contact Name:||Larry O’Leary|
Our client, a FDA regulated manufacturing company based in Cork, now seek an experienced Calibration Engineer who will lead calibrations team and provide maintenance support to operations, ensuring operational goals and objectives are achieved for the plant.
The successful candidate will oversee calibrations team, which includes generating Monthly Schedule of Calibrations for both Site & External Calibrations and then coordinating monthly Calibration schedule of works with Calibration Technicians to complete same to plan.
Responsibilities for Calibration Engineer, SME:
Manage unplanned/unscheduled calibrations as they arise.
Generate & Approve Equipment Calibration Specifications (ECS) for new Equipment in conjunction with Value Stream Engineers.
Maintain a review of existing SOP’s and update as necessary.
Create new SOP’s in Calibration as required.
Review & Approval of all on Site and External Calibration works.
Generate & manage all non-conforming events (NCEPs) in the Calibration function.
SME in the role of equipment calibrations and provide guidance/recommendations on calibration capability/reliability.
Provide training to calibration technicians as required.
Possesses a broad knowledge of the business and service provision in calibrations. Effectively understands the needs of the business and makes priority decisions accordingly.
SME for Calibrations in all internal & external quality audits & support in same in the role as audit facing SME for the Site.
Requirements for Calibration Engineer, SME:
Degree or Masters in relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc.)
4 years industry experience, 2 years’ experience of which in a relevant Calibrations Engineering role.
Experience in the use of Blue Mountain Regulatory Asset Manager (BMRAM) or equivalent system an advantage.
Excellent communications ability.
Experience in problem solving and process improvement methodologies.
Experience working with audit teams in cGMP environment.
Please phone Larry on 01-2302400 / firstname.lastname@example.org / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.