This is a full-time position, reporting to the Plant Engineering AD. The Calibration Engineer will be responsible for operational excellence in calibration management both during site build and transitioning into full operations. Working closely with the calibration technician team, the Calibration Engineer will have ownership of the calibration processes and methodologies, adherence to regulatory and industry standards, as well as troubleshooting, reliability management, and continuous improvement of the site instruments.
- Ensure calibration and instrumentation adherence to site, corporate, and regulatory requirements, safety regulations, and act 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 realization.
- Develop, implement and manage third party calibration service provider contracts.
- Develop and maintain operational budgets relating to the calibration and maintenance of process instrumentation, calibration standards, validation test equipment, and QC laboratory equipment.
- Assist management in supervising staff, contractors, and contract service providers in the performance of their routine tasks.
- Minimum 10 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 organizational 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.
- Preferably a third level qualification in Automation or Instrument Engineering or Equivalent.
- Minimum of 10 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.
- Demonstration of budgeting control and management.
- Ability to create and implement SLA’s with external vendors for calibration activities.
- Experience in management of QC laboratory instruments 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.
The job description does not intend to list all the duties and responsibilities assigned to this position. The employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and the company's business needs.
