Manager MSAT Cleaning Validation

Leiden Bio Science Park; Leiden; On-site; EUR 120,000 - 180,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden, the Netherlands, is recruiting a Manager MSAT Cleaning Validation to lead a team of 10–12 engineers and drive the cleaning validation strategy across commercial and NPIs.

The role focuses on inspection readiness, regulatory compliance, and collaboration with Operations, Quality, Engineering, R&D, and global MSAT teams to deliver robust manufacturing solutions. On‑site presence in Leiden; hybrid option with minimum 3 days on site.

Qualifications

• Education: BS degree or higher; 8+ years of relevant experience or 6+ years with an advanced degree.
• Experience in GMP, validation principles, quality management (change control, CAPA, deviations) and regulatory expectations for biologics.
• Proven leadership, ability to influence peers and partners, and experience with inspections/submissions.

Responsibilities

• Lead, coach and develop a high‑performing team of (Sr.) Engineers (staff and contractors).
• Define and drive the cleaning validation strategy and lifecycle management.
• Partner with Operations, Quality, Engineering, R&D, and global MSAT teams to ensure alignment and delivery.

Skills

Leadership

Regulatory knowledge

GMP knowledge

Cross-functional collaboration

Communication skills

Education

BS degree or equivalent

Job description

Johnson & Johnson Innovative Medicine is recruiting for a Manager MSAT Cleaning Validation, located in Leiden, the Netherlands.

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 10-12 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 & Jonshon's Compete, Execute & Optimize.
• Technical Leadership and Delivery: Provide technical leadership on defining and continuously improving 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.

Preferred Skills

• Developing Others, GMP Validation, Good Manufacturing Practices (GMP), Inclusive Leadership, Plant Operations, Process Improvements, Quality Standards, Team Management