Job Summary (Primary function)
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 DSP equipment and areas. This may include product and solution mixers, chromatography skid and packing, viral inactivation, normal filtration, viral filtration, UFDF.
During manufacturing operation, the process engineer will develop in an equipment and process engineering support role, mainly owning manufacturing scale equipment and process.
Essential Functions of the Job (Key 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 DSP 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. Up to 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 DSP equipment integration within the facility
• Lead PQ activities
During the operational 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 DSP manufacturing team members and lead by example to ensure integration of good engineering practices
• Proactively propose problem resolution to process and DSP 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
Qualifications (Minimal acceptable level of education, work experience, and competency)
• BSc, Master or 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
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.