Job Summary (Primary function)
The Calibration Engineer 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)
Responsible during the project phase to support the design development, procurement, factory acceptance testing, installation, commissioning and qualification of the Instruments utilized in the production of biopharmaceutical drug substance and maintaining the Instruments once the site is fully GMP.
During the project phase, you will mainly:
Define Instrument specifications in collaboration with key users and participate to procurement process and suppliers selection
As instrument expert, lead the definition of the Instrument criticality and develop the Calibration plan adequately
Develop procedures and work instructions for the Calibration & Metrology
Ensure that commissioning and qualification activities are performed according to GEP, GMP, GAMP respecting current technical, environmental and safety norms as well as following internal standards and Company guidelines
Review and approve project documentation (URS, FS, DS)
In collaboration with Manufacturing, QA, QC, Utilities and Warehouse department, contribute to the harmonization of the commissioning and qualification activities that are planned within the project
Contribute to project success by managing milestones and respecting defined budget
Ensure that appropriate project documentation & training is provided at projects hand over and prepare the spare part inventory at projects reception
Develop, implement and then administrate the Sites Instrument and associated calibration planning system for tracking calibration work orders, spare parts and calibration history of plant instruments
Develop the calibration troubleshooting organization
During operational phase, you will mainly:
Ensure that the Instruments are operated and maintained by strictly following the technical norms, safety rules and cGMP regulations
Keep records of Instruments failures and provide needed information and data to the equipment owners
Manage all Instruments technical related issues that will affect the day to day operation of the new plant
Ensure a complete traceability of the calibration and qualification activities following the Company's compliance procedures and cGMP rules
Contribute to the development of Sites standards
Ensure that the systems are ready for inspection at all time, 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 systems and Biotech equipment
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
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.