Technician II, Calibration

Job Responsibilities

• Ensure calibration and instrumentation adherence to site, corporate and regulatory requirements, safety regulations and acting as point of contact during all internal and external audits.
• Provide expertise input for technical instructions, best practices and standard operating procedures in the execution of calibration principles on site.
• Act as site calibrations SME for investigations, CAPAs and change controls as required.
• Develop, maintain and ensure site adherence to Calibration standards and specifications.
• Develop and sustain 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.
• Develop and lead upgrade projects, managing all aspects from concept justification to final commissioning realisation.
• Develop, implement and manage third party calibration service provider contracts.
• Maintain operational budgets relating to the calibration and maintenance of process instrumentation, calibration standards and validation test equipment and QC laboratory equipments

Requirements

• Minimum 3 years’ experience as calibration/instrument engineer in biopharmaceutical/ pharmaceutical industry during sustaining/day to day operating environment.
• Experience as a calibration/instrument engineer with responsibility for regulatory or client audit readiness and execution.
• Strong communication and presentation skills.
• Excellent organisation skills with ability to manage own work.
• Strong technical knowledge with demonstration of robust problem solving and continuous improvement.
• Must be able to work with a variety of teams, made up of both technical and non-technical personnel.
• Previous experience in oversight of site calibration compliance.
• Experience with CMMS, preferably Maximo.

Desirable

• Preferably a third level qualification in Automation or Instrument Engineering or Equivalent.
• Minimum of 3 years’ experience in a highly regulated environment- biopharmaceutical/ pharmaceutical preferable.
• Experience with a start-up or Greenfield site.
• Experience in leading site wide instrumentation projects to completion.
• Write and review calibration SOPs and work instructions
• Ability to create and implement SLA’s with external vendors for calibration activities.
• Experience in management of QC Laboratory instrument for calibration requirements.
• Coaching and facilitation skills.
• An ability to work through peers and across organizational boundaries and influence at all levels in the business.
• Ability to efficiently use current computer packages in particular Excel, PowerPoint, MS Project and Word.

Pay

Salary range for this role is $30.00-$36.00 per hour.