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.
Rotation of onsite and offsite shifts.
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&#**Apply on the website**;s degree in Automation,
Instrumentation, or other relevant engineering field. (Trade&#**Apply
on the website**;s qualified also accepted)
* 5 years&#**Apply on the website**; experience in a highly regulated
environment- biopharmaceutical/ pharmaceutical preferable.
* 3 years&#**Apply on the website**; 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&#**Apply on the website**;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) 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.
Rotation of onsite and offsite shifts.
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&#**Apply on the website**;s degree in Automation,
Instrumentation, or other relevant engineering field. (Trade&#**Apply
on the website**;s qualified also accepted)
* 5 years&#**Apply on the website**; experience in a highly regulated
environment- biopharmaceutical/ pharmaceutical preferable.
* 3 years&#**Apply on the website**; 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&#**Apply on the website**;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
