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(Sr.) Quality Engineer Pollux

Vacaturenummer: A2200106
Janssen Biologics B.V. - Leiden (Nederland)

For our client, Janssen Biologics B.V., we are looking for a (Sr.) Quality Engineer Pollux .

Keywords

  • BSc.
  • Quality documentation
  • GMP
  • New production facility
  • Validation


Profile
Are you energized to support a new organization within a global company? Do you want to contribute to improve the life of patients? Do you have a strong passion for people? Then this is your job!
Project Pollux is the establishment of a new Janssen Supply Chain Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands, to be organized as a new business unit for Janssen Biologics (JBV). This biologics manufacturing facility is intended to become a key supply option for commercial LVV in support of the global Janssen BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually.
For this project we are looking to strengthen the Pollux Quality Department with a (Senior) QA Engineer for quality oversight over the facility and equipment qualifications and production validation efforts of this new facility.
The main responsibility for the (Sr) Quality Engineer is to ensure that all qualifications/validations of the facility, utilities, equipment, automation and processes meet regulatory requirements.
To be successful as a Quality Engineer, you should demonstrate strong coaching and communication skills, a risk-based mindset, ability to zoom out and in, and great attention to details. Ultimately, an outstanding leader who should be well organized and drive Quality decisions.
Responsibilities:
  • Be the primary contact for Quality related work in the Pollux project;
  • Ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements;
  • Set GMP standards and provide Quality oversight in the project for:
  • Facility, utility, and equipment design of the new Pollux Facility;
  • Qualification and Validation of facility, utilities, equipment and processes;
  • Computer Systems Validation (CSV), including Data integrity / Part 11 guidance;
  • Analytical Equipment and Test Method Validations;
  • Review and approve qualification/ validation protocols and reports, validation assessments, URS’s and appliable technical lifecycle documentation;
  • Review and approve the outcome of Quality Investigations and Corrective/Preventive actions, related to area of responsibility;
  • Review and approve GMP documents related to the introduction of new manufacturing processes and / or analytical methods to the site;
  • Lead or assist in GMP Risk Assessments and ensure that risk-mitigations are implemented;
  • Drive a quality and compliance culture throughout the organization, e.g., via training and facility/utility walkthroughs;
  • Escalates serious quality, compliance and /or GMP incidents to Department or Project Management;
  • Acts as quality SME (Subject Matter Expert) for regulatory submissions and inspections in the area of responsibility;
  • Schedules and monitor daily QA activities in area;
  • Proactively collaborates with Site and Project Team on Best Practices and Customer needs.



Who we're looking for
For this positions we are looking for candidates with at least a Bachelors background in Biochemistry, Engineering, Biology, Pharmaceuticals and at least 4 years of experience (Medior) and >6 years of experience as Senior. You have proven experience in a Quality role in a regulated (GMP) pharmaceutical company.
Other requirements:
  • Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines;
  • Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, GMP documentation, regulations);
  • Preferably experience in a Quality role in Qualification and Validation work.

Personal:
  • Independent thinker in a complex environment, balancing business need, regulatory requirements, and cost efficiency for all Quality decisions;
  • Skilled at Risk Based Problem solving and troubleshooting;
  • Ability to drive collaboration in a fast-paced environment;
  • Connect easily at all levels in the organization and leads by example.

Are you the experienced (Medior or Senior) Quality Engineer we are looking for?


Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Department
The Pollux Quality Department a dedicated team of enthusiastic and skilled Quality professionals with various technical expertise and backgrounds, responsible for Quality Oversight over all aspects of the project, ensuring that the new facility and its operations is fit for use and meets all cGMP (and BSL) requirements.

Additional vacancy information
Reference:A2200106
Contract:Temporary contract with CLS Services
Education:WO/MSc. HBO/BSc.
Employment terms:Contract for at least one year, extension possible.
Salary: >48000
Days of leave: 36
See here our other employment terms for this vacancy
Publication date:3-8-2022
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.