Technical Specialist

Technical Specialist QC Microbiology

Location: Leiden

Working mode: Hybrid, 3 days per week on-site and 2 WFH

Duration: 12 months (opportunity for a contract extension)

Hours: Full-time, 40 hours per week

Pay rate range: Competitive hourly rate

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, hardworking and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.

Janssen Biologics in Leiden, the Netherlands is a leading production site within Janssen and part of Johnson & Johnson. At the Leiden site commercial pharmaceutical products & vaccines 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 Technical Specialist will actively handle the 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, qualifications, etc. 

roles and 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 cooperates 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 to 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.

how to succeed

• Bachelor’s degree (HLO) or higher education in Life Sciences, molecular biology or comparable

• 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.

• GMP experience is a plus

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Janssen Biologics is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. Options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.