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.