Website Asset Recruitment

Asset Recruitment

CALIBRATION ENGINEER

The Opportunity

An exciting new contract opportunity has arisen for an experienced Calibration Engineer to join our prestigious client at their advanced technology Stem Cell and Gene Therapy Manufacturing facility site in West Dublin. The Senior Calibration Engineer will be responsible for delivering the ICA Process for our clients Stem Cell and Gene Therapy Manufacturing Facility expansion project and will be supported by Project SME’s in providing the Master Calibration List so that following can be determined with the Classification Assessment Team (CAT)

§  Process Limits (Process Range) and tolerances

§  Calibrated Range

§  Calibration Tolerance

§  Process Tolerance

§  Calibration Frequency

§  Calibration test points

Profile

The Calibration Engineer will be responsible for operational excellence in calibrations management during site build and transitioning into full operations. Working closely with the Classification Assessment Team (CAT), 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. This will be a full-time on-site contract position, reporting to the senior site leadership team

Responsibilities:

§  Ensuring calibration and instrumentation adherence to site, corporate and regulatory requirements, safety regulations

§  Site calibrations SME for investigations, CAPAs and change controls as required.

§  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.

§  Developing and sustaining an instrument reliability program demonstrating tangible improvement initiatives reducing instrument related failures /discrepancies

§  Contributing to cost saving initiatives and optimizing calibration / maintenance 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.

§  Maintaining operational budgets relating to calibration and maintenance of process instrumentation, calibration standards, validation test equipment and QC lab equipment.

Requirements:

§  5 years’ experience in a biopharmaceutical manufacturing environment.

§  3 years’ experience as a calibration/instrument engineer in biopharmaceutical industry.

§  Third level Automation or Instrument Engineering qualification

§  Experience in leading site wide instrumentation projects to completion.

§  Previous experience in oversight of site calibration compliance.

§  Experience with CMMS, Maximo or similar.

§  Strong technical knowledge and robust problem-solving skills.

§  Must be able to work with a variety of technical and non-technical team members.

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