Website Asset Recruitment
Senior Calibration Engineer
Join a World Class biologics services provider at their state-of-the-art Greenfield Biopharmaceuticals CMO site in Dundalk, Co. Louth.
The Calibration Engineer will be responsible for operational excellence in calibrations management during site build and transitioning into full operations. You will report directly into the Plant Engineering A.D. and liaise with the calibration team made up of calibration technicians, a team lead and a planner.
You will play a key role in managing budgets, initiatives & cost savings on site which focus on the “bigger picture” and lead to significant changes site-wide.
This is a client facing role and also carries responsibilities as POC for all QA and compliance matters.
The successful applicant will have ownership of calibration processes and methodologies, adherence to regulatory and industry standards as well as troubleshooting, reliability management and continuous improvement of site instruments.
• Ensuring calibration and instrumentation adherence to site, corporate and regulatory requirements, safety regulations
• Point of contact during all internal and external audits.
• Providing expertise input for technical instructions, best practices and SOPs executing calibration principles on site.
• Developing, maintaining and ensuring site adherence to Calibration standards and specifications.
• Act as POC for change control, audits and preventative maintenance.
• Site calibrations SME for investigations, CAPAs and change controls as required.
• Developing and sustaining an instrument reliability program demonstrating tangible improvement initiatives reducing instrument related discrepancies / failures, contributing to cost saving initiatives, and optimizing maintenance / calibration programs for instrumentation and test equipment on site.
• Developing / implementing and managing third party calibration service provider contracts.
• Developing / lead upgrade projects, managing all aspects from concept justification to commissioning realisation.
• Developing / maintaining operational budgets relating to calibration and maintenance of process instrumentation, calibration standards and validation test equipment and QC laboratory equipment.
• Bachelor’s degree in Automation, Instrumentation, or other relevant engineering field. (Trade’s qualified also accepted)
• 5 years’ experience in a highly regulated environment- biopharmaceutical/ pharmaceutical preferable.
• 3 years’ experience as calibration/instrument engineer in biopharmaceutical/ pharmaceutical industry.
• Experience working within a start-up or Greenfield site.
• Demonstrable experience of budget control and management.
• Experience leading site-wide instrumentation projects to completion
• Previous experience in oversight of site calibration compliance
• Must have significant experience in managing problems, best practice and compliance
• Experience with CMMS, preferably Maximo
• Strong technical knowledge with demonstration of robust problem solving and continuous improvement.
• Excellent communicator and capable of working with a variety of teams
• Ability to create and implement SLA’s with external vendors for calibration activities.
• Experience in management of QC Lab instrument for calibration requirements.
• Engineering background (as opposed to just hands-on experience)