Job Summary (Primary function)
In the frame of the construction and validation of the new Incyte Biologics Facility at Yverdon-les-Bains, the Equipment Qualification Engineer is responsible to execute commissioning and qualification activities for the Utilities and / or Process systems and equipment.
The responsibilities will include supporting the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new utilities and / or equipment utilized in the production of biopharmaceutical drug substance during the construction phase and then when the site will be validated.
Essential Functions of the Job (Key responsibilities)
Responsible for the Commissioning and Qualification activities of the utilities and / or process equipment.
Ensure that equipment works to its specification
Write commissioning and qualification protocols and reports
Execute commissioning tests and qualification tests (IQ, OQ)
Participate to Factory Acceptance Test (FAT) at suppliers facilities
Prepare appropriate project documentation & hand-over
Lead and contribute to Risk analysis related to the utilities and / or process systems and equipment
Investigate problems and diagnose and repair faults
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
Provide support during Heath Authorities inspection by presenting commissioning and qualification dossiers
Provides continuous reporting on commissioning and qualification progress to ensure project milestones
In collaboration with QA department, contribute to the harmonization of the commissioning and qualification activities that are planned within the project
Provide training to maintenance and operative staff where appropriate
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)
3 to 5 years’ experience in the Biotech / Pharmaceutical manufacturing Industry
Engineering educational background preferably in Chemistry, Bioprocessing or technical engineering
Good organization and communication skills
Good knowledge of Biotech / Pharma Utilities systems and / or Biotech equipment and experience in automation systems
Good knowledge of risk assessment and control
Good knowledge of Construction & Design is a plus
Fluent in English and French
Travelling may be requires
Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP / GCP / GMP practices
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.