Join the motivated EVM team at the Janssen Vaccines & Prevention site in Leiden. We are responsible for the technical support of all utilities, production areas, and laboratory equipment. Our work is critical for commercializing vaccines in a challenging, fast-paced GMP environment. The department is focused on engineering projects, compliance/validation, and essential asset maintenance.
As the Senior Quality Engineer, you will report to the Compliance Supervisor and act as a key leader for driving quality and continuous improvement across EVM.
Your primary mission is to Ensure all maintenance, engineering, and qualification activities are delivered effectively and strictly adhere to Pharmaceutical GMP and Johnson & Johnson standards. Drive the lean culture and improve the organization’s analytical troubleshooting and efficiency through Process Excellence methodologies.
Key Responsibilities
- Act as the Subject Matter Expert (SME) for Validation and ensure EVM’s performance consistently stays within GMP boundaries.
- Facilitate and lead the ongoing improvements program using advanced PE methodologies (e.g., Six Sigma Greenbelt).
- Develop, implement, and maintain a system to visualize EVM performance, metrics, and trends across all sub-departments.
- Provide expert team support in handling and following up on complex quality issues, including CAPA's, Events, and Deviations.
- Support all EVM sub-groups (U&B, Automation, Equipment) in optimizing and aligning their internal processes and communication flow.
- Conduct internal audits, serve as the EVM Quality Representative, and proactively align activities with all business partners.
Functie-eisen
- Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Installation Technics, or Process Engineering.
- Minimum of 4 to 8 years of relevant work experience as a Quality Engineer OR several years of experience in a GMP environment with a strong focus on Process Excellence and Quality.
- GMP Expertise; Strong understanding of GMP requirements (e.g., Annex 11, FDA, ICH, ISPE) and the qualification/validation aspects of pharmaceutical/bioprocessing equipment and facilities.
- Proven experience in Process Excellence and risk analysis.
- Excellent communication skills for process alignment and team support.
- Yellowbelt and/or Greenbelt certified in Process Excellence/Six Sigma.
- Experience working in a maintenance or engineering organization within the biotechnology, pharmaceutical, or process industry.
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
At Janssen Biologics, you'll be part of a global market leader and a highly motivated team that is passionate about its work. We are committed to fostering your personal and professional growth with opportunities to work on exciting projects and assignments.
- Flexible working hours.
- Excellent benefits and competitive compensation.
- A dynamic and inspiring work environment.
- Continuous professional development and educational opportunities.
- The chance to make a real impact on the lives of patients.
- Duration: 12-month contract
- Hours: 40 hours per week
- Work Model: Hybrid (3 days on-site)
Bedrijfsinformatie
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Sowmya Kandukuri
sowmya.kandukuri@yacht.nl
+918374294984
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