Manager MSAT Cleaning Validation

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Johnson & Johnson Innovative Medicine is recruiting for a Manager MSAT Cleaning Validation located in Leiden the Netherlands. Do you want to join our team

The Leiden MSAT team plays a key role in driving technical leadership for biotherapeutics manufacturing at the Leiden site. The team is responsible for process technology strategy commercial process lifecycle management and maintaining the validated state of manufacturing processes. We partner closely with Operations Quality Engineering R&D and global MSAT stakeholders to deliver robust compliant and future-ready manufacturing solutions.

As Manager MSAT Cleaning Validation you will lead and develop a team of (Sr) Engineers (both staff and contractors) with an expected team size of approximately 1012 FTEs. You will define and drive the overall cleaning validation strategy ensure delivery against commitments for both the commercial portfolio and new product introductions (NPIs) and contribute directly to MSAT Biotherapeutics objectives. You will play a critical role in enabling inspection readiness and strengthening validation excellence!

Key Responsibilities:

Leadership and Team Development: Lead coach and inspire a high-performing technical team of (Sr.) Engineers. Build a culture of accountability collaboration inclusion and continuous development. Promote a safety and quality-first mentality in all validation activities and stakeholder interactions. Drive an inclusive and collaborative Credo-based culture aligned with our guiding principles of Johnson & Jonshons Compete Execute & Optimize.

Technical Leadership and Delivery: Provide technical leadership on defining and continously improve the cleaning validation strategy and validation lifecycle management activities. Ensure compliance with current GMP guidelines industry standards and regulatory requirements to guarantee inspection readiness and support successful commercial clinical and PPQ manufacturing. Drive performance through technical innovation and standardization.

Partnership: Partner effectively and collaboratively with site and global partners to align priorities shape execution strategy and risks management. Build strong cross-functional relationships with Operations Quality Engineering R&D TDS and global MSAT teams to ensure effective collaboration and sustainable outcomes.

Qualifications

Education:

8 years of relevant experience and BS degree or equivalent OR 6 years with advanced degree MS/MBA/Ph.D. or equivalent.

Experience and Skills:

Required:

• Proven leadership experience

• Demonstrate effective talent management understanding and respecting different backgrounds and perspectives

• Ability to foster team productivity and cohesiveness and to work collaboratively across functions

• Experience on GMP validation principles quality management (change control CAPA deviation/investigation processes) and regulatory expectations for biologics manufacturing

• Experience supporting inspections and regulatory submissions. Demonstrates knowledge of relevant regulatory agencies (e.g. FDA EMA) and industry standards (e.g. PDA ISPE ISO ICH WHO) compliance expectations.

• Proven effective communication skills at all levels written and oral.

• Ability to influence peers senior leadership and partners

Preferred:

• Experience in the pharmaceutical or biotechnology industry preferably in BioTherapeutics Drug Substance with people leader role.

• Proven experience in supporting process validation such as cleaning processes and sterilization processes

• Knowledge of both Pharmaceutical Manufacturing and experience with Biotherapeutics and/or Parenterals

• 6-Sigma/Lean or similar problem solving/decision making methodology

Other:

• Fluent proficiency in English Basic understanding of Dutch is preferred

• On site presence in Leiden . Hybrid possible with minimum of 3 days on site.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.