As a senior quality engineer, you will be reporting to the compliance supervisor. You will be the key person to provide leadership and support on the continuous improvements of both our internal and external business processes.
Your main focus will be on;
- Quality and GMP related aspects of the maintenance/engineering and qualification activities, which will assure that our technical support is delivered within the compliance regulations of the Pharmaceutical and Johnson & Johnson standards and guidelines in an effective way.
- All Process Excellence related processes and projects which will further embed and improve the lean culture and analytical troubleshooting capabilities of the organization.
Furthermore you will;
- Be facilitating the ongoing improvements program within EVM.
- Subject matter expert on Validation activities.
- Provide support to all sub-groups within EVM in optimizing and aligning their internal processes and communication
- Utilize multifaceted industry and process excellence methodologies on an expert level (e.g. 6-sigma, greenbelt methodologies)
- Implement/maintain a system capable of visualizing the EVM performance and metrics Key Milestones and Actions. Set-up metrics and trend per sub-department.
- Be in the lead of the process to safeguard EVM’s performance within GMP boundaries
- Provide complex team support to all sub groups within EVM on handling and follow up of CAPA’s, Events, deviations etc.
- Ensuring comprehensive measurement systems to monitor the effectiveness of quality and critical systems.
- Pro-actively seeking contact with all business partners of EVM to adjust and align the interaction.
- Conducting & following internal audits
- Be the Quality representative of EVM
- Support engineering, maintenance with advise on Process Excellence (PE) aspects usage in maintenance and project execution
Functie-eisen
- Experience in Process Excellence.
- Yellow & Greenbelt certified preferred.
- Good skills in communication, risk analyses, understanding GMP requirements (Annex 11),Validation and qualification aspects of pharmaceutical and/or bio processing equipment, utilities and facilities.
- Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and Validation (e.g. FDA, GMP, ICH, ASTM, ISPE, etc.)
- Minimum of 4-8 years work experience in similar job as quality engineer.
- Or several years of work experience in GMP environment with relevant projects/experiences related to Process Excellence and Quality
Competenties
- Strong communicator and team player, good in building relations with variety of people and departments
- High degree of accuracy, initiative, and independence.
- Flexible, can deal with changing priorities and stress resistant.
- Enthusiastic Team player, flexible, “Can do” attitude, critical and proactive.
- Analytical and organized
- Quality & critical mindset
- Open for continues improvement and development of organization, processes and people.
Arbeidsvoorwaarden
- Discount on the collective health insurance scheme via Zilveren Kruis
- Access to the YACHT network of companies and industry specialists
- A favorable pension scheme (STIPP)
- 8 % holiday allowance
- Good travel allowance of €0.21 per km
- Training budget provided by Yacht: €3,500 per year
- A one-time home office allowance of €750
- Soft skills coaching
Location: Leiden, Netherlands - Hybrid working - 3 days a week on site
Duration: 6 months
Bedrijfsinformatie
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-skilled people are working in a high-performing culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Compliance team in Engineering, Validation and Maintenance (EVM) department we are looking for an enthusiastic and dedicated:
The Engineering-Validation-Maintenance (EVM) department (> 35 persons) is a motivated and dynamic team responsible for the technical support of all utilities, production and laboratory areas and all involved equipment at the Janssen Vaccines & Prevention site in Leiden.
We work in a challenging environment where we make great progress in commercializing our vaccines. Engineering has a large project portfolio to sustain/improve the existing environment. The Compliance group looks after the correct qualification and validation status of GMP critical equipment and processes. Furthermore, the compliance group is responsible for the overall quality and safety programs within EVM. The key-focus point of the maintenance groups (U&B, Automation and Equipment group) is asset maintenance management of all assets within JVP.
Randstad Life Sciences | Pharma
Randstad is a leading Dutch recruitment and secondment agency that connects highly qualified professionals with forward-thinking organizations. As part of Randstad Group Netherlands, Randstad Life Sciences is a premier talent partner in the Dutch Life Sciences, Pharma, and Biotech sectors. Yacht places ambitious professionals in meaningful roles at top-tier organizations such as Astellas, Danone, Philips, and Johnson & Johnson.
In one of the fastest-growing sectors in the Netherlands, Yacht Life Sciences offers both project-based assignments and permanent positions that contribute to the development of medical devices, therapies, and medicines aimed at improving global health.
Professionals partnering with Randstad benefit from:
- Access to a robust network of industry experts and innovative companies
- Opportunities to participate in R&D projects, clinical trials, and quality & regulatory initiatives
- Continuous development through training, courses, and knowledge-sharing sessions
- A personalized career path shaped by your ambitions and supported by dedicated coaches and consultants
Contactinformatie
Apply now and you will receive a WhatsApp message within 15 minutes with a few short questions, so we can help you quickly. Don’t have WhatsApp? No problem, we will contact you via phone or email!
For more information, please contact Nicole Miggels at 06-13897074.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Nicole Miggels
nicole.miggels@randstadprofessional.nl
06-13897074
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