ob Summary (Primary function)
The Calibration Specialist for the new Incyte Biologics Facility at Yverdon-les-Bains is responsible for all the activities related to Instruments utilized in the production of biopharmaceutical drug substance, QC lab, MSAT lab, warehouse and Utilities. You will be part of an exciting & motivated group and will report to the Director of the Site Engineering.
Essential Functions of the Job (Key responsibilities)
- The Calibration Specialist for the new Incyte Biologics Facility at Yverdon-les-Bains is responsible for all the activities related to Instruments utilized in the production of biopharmaceutical drug substance, QC lab, MSAT lab, warehouse and Utilities. You will be part of an exciting & motivated group and will report to the Director of the Site Engineering
- As instrument expert, lead the definition of the Instrument criticality and develop the Calibration plan adequately.
- Ensure procedures and work instructions for the Calibration & Metrology are created and up to date.
- Ensure that qualification periodical requalification activities are perforrmed according to GEP, GMP, GAMP respecting current technical, environmental and safety norms as well as following internal standards and Company guidelines.
- Define Instrument specifications in collaboration with key users and participate to procurement process and suppliers selection.
- Review and approve project documentation as metrology expert (URS, FS, DS).
- In collaboration with Manufacturing, QA, QC, Utilities and Warehouse department, contribute to the harmonization of the Calibration and Qualification activities that are planned.
- Ensure that Calibration Plans are created and executed time according to procedures.
- Ensure that spare part inventory is up to date at reception of installations and for equipment sustainability.
- Develop, implement and then administrate the Site’s Instrument and associated calibration planning system for tracking calibration work orders, spare parts and calibration history of plant instruments.
- Provide required support in HVAC, LAF, BSC and climatic chambers qualification and re-qualification activities, strategy definition, protocol and report writing execution follow-up.
- Develop, in collaboration with the metrology department team and the head of Engineering, the calibration troubleshooting organization.
- Ensure that the Instruments are operated and maintained by strictly following the technical norms, safety rules and cGMP regulations.
- Definition and follow-up of KPIs for Calibration activities and instrument historical.
- Ensure a complete traceability of the calibration and qualification activities following the Company's compliance procedures and cGMP rules.
- Lead the technical investigation of Instrumentation scope, and application of common investigations methods (6M).
- Contribute to the development of Site’s standards.
- Ensure that the systems are ready for inspection at all times, provide support during regulatory inspections and present subjects when required.
- Ensure close collaboration with operation users and QA and contribute to continuous improvement of the systems and processes overall.
- Ensure that all procedures and technical documents are updated according to the Site quality documentation systems.
- Stay up to date on latest industry standards.
- Ensure safe working conditions.
- Contribute positively to a strong culture of business integrity and ethics.
- Act within compliance and legal requirements as well as within company guidelines.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Technical and/or Engineering educational background preferably in Mechanics, Electricity, Automation.
- Minimum of 5+ years of experience in the pharma/biotech manufacturing environment.
- Good knowledge of Biotech/Pharma Utilities/HVAC systems and Biotech equipment.
- Minimum of 3+ years of experience in Metrology and Calibration activities.
- Knowledge of HVAC qualification activities (ISO-14644) is a plus.
- Broad knowledge of Pharmaceutical Quality, Manufacturing and cGMP practices.
- Strong interpersonal and communications skills; written and oral.
- Fluent in English and French.
- Travelling may be required.