During the construction and facility startup phase you will be the process engineer responsible for process and equipment design and responsible to support the 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 process engineer will develop in an equipment and process engineering support role, mainly owning manufacturing scale equipment and process.
During manufacturing operation, the process engineer will develop in an equipment and process engineering support role, mainly owning manufacturing scale equipment and process.
Duties and Responsibilities
During the construction phase, you will mainly:
Lead process and equipment FMEA risk assessment, GMP reviews
Author, review and maintain comprehensive systems requirements (URS)
Lead the definition of USP process equipment Functional Specifications
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
Support FAT, SAT, IQ, Commissioning and OQ. Upto 25% European travel required
Support the development and implementation of process validation plans including protocols in cooperation with the Validation/Qualification Group
Assess Change Controls and deviations including any corrective actions arising during verifications
Revise and approve test reports
Support USP equipment integration within the facility
Lead PQ activities
During the operation phase, you will mainly:
Author, review, approve, maintain life cycle (…etc.) all required Standard Operating Procedures, Work Instructions, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
Act as a mentor to USP manufacturing team members and lead by example to ensure integration of good engineering practices
Proactively propose problem resolution to process and USP equipment
Assess events, deviations and non-conformances
Raise, investigate, assess and close Change Controls.
Prepare and deliver process and technology overview training
Actively participate in process and technology transfer
Requirements
BSc, Masteror Engineering Degree in Pharma/Biotech engineering
Relevant experience in biotech industry related to cGMP drug manufacturing, process design, equipment qualification, change control, equipment modification, and process validation
Direct experience in FMEA, root cause analysis, and associated quality assessment tools
Typically minimum 5-7 years of experience
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
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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.