Senior Engineer, Quality Assurance CSV

☞ Incyte

View: 178

Update day: 25-04-2024

Location: Yverdon-les-Bains Vaud VD

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Biotechnology Research

Position: Associate

Job type: Full-time

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Job content

Job Summary (Primary Function)

Supports the Quality Assurance engineering activities associated with the design, construction, start-up of a new green-field large scale API bio-manufacturing facility. Responsibilities will 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 utilized in the production. Specifically this position will support all qualification and validation activities of computerized and automated systems (MES, EBR, PLC/SCADA, EMS, LIMS, ERP systems) of biopharmaceutical drug substance manufacturing according to quality policies, cGMP, Swiss, EU / US FDA Regulations.

Essential Functions Of The Job (Key Responsibilities)
  • Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES, EBR, PLC/SCADA, EMS, LIMS, ERP systems)
  • Work with the project team and the engineering companies on the detailed design deliverables concerning Computerized and Automated (SISA) systems requirements
  • Review and approve the URS and relevant design documentation
  • Support actively the risk assessment exercises
  • Review and approve Computerized and Automated (SISA) systems related documentation (procedures, 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
  • Create SOPs for Automated and Computerized systems qualification / validation including 21CFR part 11 and data integrity requirements
  • Ensure alignment with global Quality Assurance CSV organization
  • Perform quality audits for computerized and automated systems suppliers if needed
  • Ensure qualification and validation of all systems in close collaboration with process engineering & automation teams
  • At all times work in view of the site readiness for regulatory inspections (Swissmedic and International)
  • 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 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 computerized and automated systems (MES, PLC SCADA systems, EMS, LIMS, ERP 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
  • 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.

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Deadline: 09-06-2024

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