Vacature Senior Engineer Msat LM Validation

Senior Engineer MSAT LM Validation - Fixed Term

• Engineering
• Process Engineering
• Leiden, South Holland, Netherlands
• 11 07 2023
• 23W

Senior Engineer MSAT LM Validation - Fixed Term

4 Day work week possible

Janssen Biologics B.V., a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Engineer MSAT to be based in Leiden, the Netherlands. Our site produces biotherapeutic drug substance and is growing our portfolio to include novel advance therapeutic medicinal products.

The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation (SPV), technical product ownership and key driver of sophisticated technologies to enable the best value for patients.

The Senior Engineer is a member of the MSAT-SPV Team with the dedicated focus on:

1. Validation of Supporting Processes (e.g. cleaning, mixing, sterilization, thermal).

2. Process improvements, benchmarking and standardization.

3. New technology deployment.

Job Duties and Responsibilities:

• Assess, plan and coordinate execution of SPV activities such as qualification of cleaning, sterilization, and mixing processes.
• Support projects as a core team member responsible for qualification activities providing regular status updates in a timely manner.
• Act as SME for one or more validation categories. Leverage global MSAT network to identify and implement best practices.
• Act as a mentor or coach for more junior engineers.
• Support the department's perpetual audit readiness initiative and represent MSAT in audits and inspections
• Support the site change control program by performing validation impact assessments delivering the resulting implementation plan.
• Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.)

Minimum Qualification and Requirements

• Bachelor's degree or equivalent in Science, Engineering or Technical subject
• Minimum 4 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Skills in communication, planning, documentation practices, risk management, root cause problem solving and knowledge management.
• Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and validation (e.g. FDA, GMP, ICH, ASTM, ISPE, PDA etc.)

Preferred:

• Experience in qualification of moist heat sterilization processes (autoclaves, steam in place) and/or isolator with robotic filling technology (aseptic process simulation, smoke studies, VHP decontamination).
• 6-Sigma/Lean or similar continuous improvement methodology experience.

What we offer:

Janssen Biologics in Leiden, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Advance Therapeutic Medicinal Products. We combine our proven strengths with innovation to meet the needs of today and tomorrow. At Janssen Biologics, enthusiastic people are working together in a dynamic culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and contribute to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark!

Your development is key to us, and we consider it our day-to-day responsibility. We believe we can make a difference together and take your career seriously. Through on-the-job and development trainings, assignment to projects and programs, we are committed to your personal and professional growth. Via multiple employee benefits, our company offers support for you and your family now and in the future.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	engineer msat lm validation
Startdatum:	21-11-2023
Ervaring:	Ervaren
Educatielevel:	WO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Johnson & Johnson via onbekend of onbekend. Of bezoek hun website onbekend.