Yacht Life Sciences has a vacancy for a Quality Engineer to work at Janssen Biologics in Sassenheim.
To strengthen the Pollux Quality Department we are looking for a QA Engineer for review and approval of qualification protocols and reports and technical documentation of this new facility.
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.
We are looking for a dedicated individual to join our Pollux Quality team as a Quality Engineer. The main responsibility for the 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.
The responsibilities and the impact you will have:
- Be a 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.
- 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 walk-throughs.
- 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.
- Proven experience in a Quality role in the biotechnical or pharmaceutical industry.
- Bachelor’s degree or higher in Biochemistry, Engineering, Biology, Pharmaceuticals, or other relevant education.
- >3 years of similar experience in a GMP regulated environment.
- Preference for a Quality role in Qualification and Validation work.
- 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).
- Proficiency in English both in word and in writing.
- Work from Sassenheim, 100% availability on site.
- 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.
- Manages diversity and conflicting viewpoints.
- Empowered professional who can make well motivated pragmatic decisions on their own.
This concerns a secondment contract with Yacht to work at Janssen Biologics (J&J) for 1 year, extension is anticipated. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefit package in line with the seniority of the position (salary between 4200 and 5500 euro gross per 4 week period).
This role can be performed on a freelance/ ZZP base as well.
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.
The Pollux production facility is currently under initial design development, with the following milestones in the long-lead project plan:
- Completion of preliminary engineering (Basis of Design)
- Completion of full (detailed) design
- Facility construction and building commissioning
- Facility and production equipment qualification
- Producing validation batches, site approval, start routine production
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.