Job Summary (Primary function)
Supports the Quality Assurance engineering and operation activities associated with the design, construction, start-up of a new green-field large scale API bio-manufacturing facility. Responsibilities include supporting the design, qualification and validation during the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment used for manufacturing. Specifically this position will support all qualification activities for Media Preparation, Buffer Preparation, Washing Area, Upstream and Downstream equipment according to Quality policies, cGMP, Swiss, EU and US FDA Regulations.
Once the new site will be qualified, this position will support the implementation and performance of site manufacturing operations.
Essential Functions of the Job (Key responsibilities)
Responsible for the Commissioning and Qualification activities of the utilities and/or process equipment.
• Act as the main point of contact for all quality compliance key topics regarding Process Equipment
• Work with the project team and the engineering companies on the detailed design deliverables concerning Process Equipment requirements
• Review and approve the URS and relevant design documentation
• Support actively the risk assessment exercises (FMECA)
• Review and approve Process Equipment related documentation (procedures, layouts, FAT/SAT protocols and reports, qualification protocols and reports, CAPAs, deviations and change controls) to ensure compliance with cGMP and applicable regulations
• Support the Commissioning & Qualification activities during FAT at suppliers and on site
• Create SOPs for Process Equipment qualification / validation
• Conduct supplier’s audit as well as self-inspections
• Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams
• At all times work in view of the site readiness for regulatory inspections (Swissmedic and International)
• Once qualified, support the implementations and performance of Quality operations (batch records review, change controls review and approval, periodic reviews, change-over management and other)
• 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)
• Must speak, read and write in English and French
• Must have minimum of 5 years in a quality assurance engineering role in a biopharmaceutical manufacturing environment
• Thorough knowledge of biotechnological technologies, processes, with a demonstrated experience in Process Equipment systems
• Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation
• Must have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems
• Experience in health authorities inspections
• The ability to make pragmatic and compliant decisions
• Strong result orientation and committed team member
• Flexibility and ability to travel up to 25% during project
• Excellent written and verbal communication skills.
• Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
• Advanced degree preferred
• Strong experience of Quality Assurance engineering and specifically on qualification and validation activities
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.