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.
RESPONSIBILITIES:
? 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.
REQUIREMENTS:
? 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) 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.
RESPONSIBILITIES:
? 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.
REQUIREMENTS:
? 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)
We need : English (Good)
Type: Permanent
Payment:
Category: Others
