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.
Job Description:
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
Education: Bachelor degree preferably in one of the following disciplines: Mechanical engineering, Electrical engineering, Installation Technics or Process Engineering
Specific Knowledge:
· 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.)
Preferably:
· Experience in a maintenance or engineering organization within biotechnology/pharmaceutical/process industry environment.
Experience:
· 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.
Two interview stages via Teams:
- First with hiring manager and a colleague.
- Second with another colleague.
Shortlisting Monday Morning
Notice period: Ideally less than 2 months; 1 month is acceptable.
Arbeidsvoorwaarden
- Duration: 1-year contractor role with potential for extension.
- Working model: Hybrid – 3 days onsite, 2 days remote.
- One-year contract with the intention to offer a permanent contract afterward.
- Discount on the collective health insurance plan via Zilveren Kruis.
- Access to the Yacht network of companies and industry specialists.
- Generous referral program – up to €1,500.
- Attractive pension scheme (STIPP).
- 8.33% holiday allowance.
- Commuting reimbursement – €0.23 per kilometer up to 26km one way.
- Soft skills coaching – you’ll be assigned a coach (if desired) from your professional field to spar with and guide you. Additionally, you’ll have a dedicated Yacht contact person to help shape your career ambitions and create a development plan together
Bedrijfsinformatie
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated diseases are prevented, treated, and cured, where treatments are more inquisitive and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
YACHT Life sciences
Yacht is a leading Dutch recruitment and secondment agency that connects highly skilled professionals with forward-thinking organizations. As part of Randstad Group Netherlands,Yacht Life Sciences, is a leading talent partner in the Dutch Life Sciences, Pharma, and Biotech sectors. Yacht connects ambitious professionals with impactful roles at top organizations such as Astellas, Danone, Philips, and Johnson & Johnson.
Operating in one of the fastest-growing industries in the Netherlands, Yacht Life Sciences offers both project-based assignments and permanent positions that contribute to the development of medical devices, therapies, and medications aimed at improving global health.
Professionals working with Yacht benefit from:
- Access to a strong network of industry experts and innovative companies.
- Opportunities to participate in R&D projects, clinical studies, and quality & regulatory initiatives.
- Continuous development through training, courses, and knowledge-sharing events.
- A personalized career path shaped by your ambitions and supported by dedicated coaches and consultants.
r
Contactinformatie
Voor meer informatie neem contact op met Nicole Miggels 06-13897074
Een baan via Yacht Engineering
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? 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!
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Nicole Miggels
nicole.miggels@yacht.nl
06-13897074
Zo verloopt het solliciteren via Randstad Professional | Yacht. Ontdek hoe we jou kunnen helpen om een baan te vinden.
Je sollicitatie en cv worden doorgenomen door Nicole Miggels
Binnen 5 werkdagen ontvang je een reactie
Is er een match, dan plannen we een persoonlijke kennismaking
We onderzoeken samen jouw ambitie en mogelijkheden
Daarna word je (eventueel) voorgesteld bij onze opdrachtgever
Wanneer de klik er is, ga je starten bij je nieuwe uitdaging!
Afhankelijk van het soort dienstverband (interim, zzp of vast), ontvang je van ons een aanbod
