Job Summary (Primary function)
During the construction and facility startup phase, the Production Technologist Manager will be responsible for commissioning and qualification of USP equipment and areas.
This may include medium preparation, inoculum, bioreactors (rockers, STR), depth filtration, and cell clarification equipment.
During manufacturing operation, the Production Technologist Manager will develop in an operation based role such as subject matter expert for area of responsibility and / or shift supervisor.
Essential Functions of the Job (Key responsibilities)
During the construction phase, you will mainly :
Author, 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
Own (develop, document, apply, close) Change Controls and deviations including any corrective actions arising during verifications
Revise and approve test reports
Perform and report PQ activities
Prepare and deliver training to new members of the team
During the operation phase, you will mainly :
Author, review, approve, maintain life cycle ( etc.) of 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 a mentor to more junior team members and lead by example to ensure timely batch execution, and proactively propose problem resolution
Raise, investigate and close events, deviations and non-conformances
Manage, plan, lead and execute batch related activities
Qualifications (Minimal acceptable level of education, work experience, and competency)
Biotechnology or pharmaceutical BSc (e.g. Swiss HES) degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
Must have hands-on experience of equipment commissioning and qualification
Demonstrated, solid hands on experience of USP manufacturing typically 4 years
Shift work is expected
Ability to work in a fast paced high regulated environment
French and English (Fluent)
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.