Job Summary (Primary function)
During the construction and facility startup phase, the Downstream Production Technician will be responsible for executing commissioning and qualification protocols of DSP equipment and areas.
This may include product and solution mixers, chromatography skid and packing, viral inactivation, normal filtration, viral Filtration, UFDF, etc.
During manufacturing operation, the Downstream Production Technician will develop in an operations based role.
Essential Functions of the Job (Key responsibilities)
During the construction phase, you will mainly :
Draft, review and maintain comprehensive systems requirements (URS)
Actively participate in the definition and review of the Qualification Master Plan
Review Vendor Quality & Project Plans and Qualification / Test Plans
Actively participate in Regular calls, visits, status updates with process equipment manufacturers
Perform FAT, SAT, IQ, Commissioning and OQ. Up to 25% European travel required
Support Change Controls and deviations including any corrective actions arising during verifications
Execute and review test reports
Perform and report PQ activities
Prepare and deliver training to new members of the team
During operational phase, you will mainly :
Draft, review all required Standard Operating Procedures, Work Instructions, Manufacturing Batch Records, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
Act as an example in the cleanroom to ensure timely batch execution, and proactively propose problem resolution
Raise, investigate and close events, deviations and non-conformances
Execute batch related activities
Actively participate in continuous improvement initiatives - proposing and implementing with team
Qualifications (Minimal acceptable level of education, work experience, and competency)
Biotechnology or pharmaceutical degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
Demonstrated, hands on experience of DSP manufacturing
Shift work is expected
Ability to work in a fast paced high regulated environment
French and English
Team work oriented mindset
Contribute positively to a strong culture of business integrity and ethics
Act within compliance and legal requirements as well as within company guidelines
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.