Job offer from Thursday, May 16, 2019

Engineer II Calibration

IncyteYverdon-les-Bains VD
  • Yverdon-les-Bains VD
  • Small and medium-sized enterprises
  • Unlimited employment, 100%
  • Position with re­spon­si­bil­i­ties

Engineer II Calibration

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 project’s hand over and prepare the spare part inventory at project’s reception
•  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
•  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 Instrument’s 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 Site’s 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.

Route de la Corniche 1 1066 Epalinges

6 jobs — Yverdon les Bains

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