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Johnson & Johnson · 1 month ago

Senior Scientist, Process Validation

New Brunswick, New Jersey, United States of America

Full-time

Hybrid

Mid, Senior Level

$94K/yr - $144K/yr

7+ years exp

Johnson & Johnson is a leading healthcare company focused on innovative medicine and patient care. They are seeking a Senior Scientist in Process Validation to develop and implement validation strategies for advanced therapies, ensuring compliance and innovation across their manufacturing network.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

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

Process Validation StrategyRegulatory ComplianceRisk-Based ValidationStatistical Process ControlDigital Solution ImplementationData Management PlatformsCoachingManufacturing PracticesInnovationProactive BehaviorCommunicationCritical ThinkingProblem Solving

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

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)