TECHNICAL SPECIALIST QC MICROBIOLOGY

About the Company Janssen Biologics in Leiden, the Netherlands, is a leading production site within Janssen and part of Johnson & Johnson Innovative Medicine.
At the Leiden site commercial pharmaceutical products are being produced and new products are being developed and produced for clinical trials and early launch.
At Janssen hardworking people are working together in a dynamic culture where innovation and a 'can do' state of mind are common good.
We are proud of our Credo & diverse culture.
The site is steadily growing and redefining to support our patients, while committing to the highest safety & sustainability standards! The responsibilities & the impact YOU will have.
The Technical Specialist will actively handle medium and high quality and compliance issues at the lab independently or with help of the lab technicians.
Will work to maintain cGMP compliance and LEAN status of the team.
Act as Subject Matter Authority during cGMP inspections and is SPOC (Single Point of Contact) for the lab during new product implementations, investigations and qualifications.
Your key responsibilities.
• Responsible for deviation management, acting as lead investigator for non-conformances and coordinator of appropriate corrective/preventive actions.
• Creates, reviews and updates lab documentation and supporting documents for New Product Introductions.
• Provides technical support to the lab, input in services group and collaborates with local/global customers.
• Acts as a technical system owner for (analytical) equipment.
• Acting as Subject Matter Authority during audits and inspections.
• Leads and drives continuous improvement projects.
• Role model for safety, compliance, and reliability.
• Responsible to communicate and interact effectively with team members, develop credibility and trusted mutually respected relationships with customers, supervisors, and team members.
Qualifications We would love to hear from YOU, if you have the following requirements.
• Bachelor's Degree in Life Sciences or equivalent, possibly with a higher qualification.
• Requires strong typing, written and oral communication skills in English • Ability to work independently as well as collaborate with cross-functional teams to accept challenges and responsibilities • Proven experience with microbiological techniques, such as bioburden, endotoxin, and sterility is preferred.
• Analytical thinking and (technical) problem solving.
Lean/Six Sigma experience is highly desirable • GMP experience is a plus This is what awaits YOU at J&J.
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities.
At Johnson & Johnson our culture enables dynamic and impactful careers.
We share a kind of DNA where we’re each.
We offer.
• Flexible working hours • An opportunity to be part of a global market leader • Being part of highly motivated team • A dynamic and inspiring working environment • Many opportunities to work on exciting projects and assignments • Possibilities for further personal and professional development/education • Excellent record in employee continuous professional development • Multiple employee benefits Does this describe you? Then we might be a match! Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
About Johnson & Johnson At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter 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.
Learn more at https://www.
nj.
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