Johnson & Johnson Innovative Medicine · 1 week ago
Senior Scientist, Process Validation
New Brunswick, NJ
Full-time
Hybrid
Mid, Senior Level
$94K/yr - $144K/yr
7+ years expJohnson & Johnson is a leader in healthcare innovation, committed to developing transformative therapies for complex diseases. The Senior Scientist, Process Validation will be responsible for developing and governing validation strategies across the Advanced Therapies network, ensuring compliance and innovation in the manufacturing processes.
Pharmaceuticals
Responsibilities
Define and maintain global Validation Master Plans and governance frameworks for ATMP processes
Drive global implementation of risk-based validation approaches aligned with ICH Q8/Q9/Q10, Annex 15, and FDA/EMA guidance
Author harmonized validation standards and templates across the global network
Provide strategic oversight for PPQ campaigns implemented at multiple sites, ensuring consistency and compliance
Support global CPV strategy, apply data analytics, statistical tools, and risk management principles to evaluate process capability and drive data-informed decisions
Support lifecycle improvement initiatives and evaluate digital tools for process monitoring
Partner with regional and site teams to assess validation readiness for new technologies and platforms
Support and author regulatory submissions with globally aligned validation documentation and strategies
Act as an inspiring leader, mentoring teams and influencing global validation policy and innovation
Facilitate collaboration and communicate program goals, progress, risks, and results to senior leadership and technical teams with clarity and influence
Qualification
Required
Bachelor's degree in biology, biotechnology, or related scientific field is required; advanced degree or equivalent experience preferred
7+ years proven experience within a regulated biologics or pharma industry
Experience in global process validation strategy, governance, and regulatory compliance for ATMPs
Strong understanding of risk-based validation principles and Health Authority expectations
Demonstrate the ability to work effectively in cross-functional environment and influence global teams
Preferred
Prior experience in cell culture or viral vector commercial manufacturing is highly desired
Knowledge in statistical process control and analytical data modeling
Experience in digital solution implementation and deployment
Knowledge in data management platforms and data governance
Benefits
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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