Calibration Engineer SME, Biopharma
|Job Title:||Calibration Engineer SME, Biopharma|
|Contact Name:||Larry O’Leary|
|Job Published:||5 months ago|
Our client, a multinational biopharma company, now seek a Calibration Subject Matter Expert (SME) in the maintaining of the calibration programme within the Site Engineering organisation.
The successful candidate will be SME and leader for the site calibration programme who works with cross-functional teams to ensure that there is an effective and robust calibration system developed and implemented at the site. Additionally, this hire will provide supervision and coordination of all Calibration contractors on site.
This hire will perform maintenance, installation, troubleshooting, calibration and repair of a variety of electronic components, analytical equipment, controls and instruments for site wide laboratory and biologics manufacturing equipment.
Responsibilities of Calibration Engineer SME, Biopharma:
Provide technical direction, supervision and input for maintaining and operating the calibration programme.
Responsible for designing and implementing a best-in-class site calibration programme.
Implement a calibration program for assets to support manufacturing and prevent unplanned downtime.
Act as SME presenting at internal and external audits, developing and delivering training, and managing technical specifications and documentation.
Assist with vendor calibration support to equipment; including audits and contracted services to per site requirements.
Investigate failures and instruments that are out of tolerance, and determine acceptability of product and processes. Assist in the preparation of documentation of investigation findings.
Assists with development and implementation of technically defensible calibration procedures and new instruments being considered at the Facility.
Coordinates the assigned activities and schedules of calibrations throughout the facility, including routine and non-routine work.
Work closely with the Reliability team to develop & introduce a critical instrumentation asset management plan by identifying aging & vulnerable instrumentation across the site, whilst ensuring that the calibration improvement projects are included in the capital plan.
Requirements for Calibration Engineer SME, Biopharma:
Honours Bachelor’s degree in Metrology or Instrumentation or equivalent.
6 plus years’ plus industrial experience, with at least 5 years in biopharmaceutical manufacturing, pharmaceuticals or equivalent GMP environment.
Proven knowledge of Metrology concepts, including accuracy, precision and uncertainty. Must be able to deal with complex processes.
A team player prepared to lead, work in and embrace an interdependent working culture.
Ability to lead teams and medium size projects.
Must have proficient knowledge of CMMS and automated calibration management systems.
Proficient with P&IDs and advanced understanding of instrumentation, process and controls.
Proficient with PLC and digital based control systems and their instrumentation interfaces.
Please phone Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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