Senior Scientist, Process Validation

Johnson & Johnson•New Brunswick, NJ

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Supply Chain Manufacturing Job Sub Function: Manufacturing Deployment Job Category: Professional All Job Posting Locations: New Brunswick, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Scientist, Process Validation to be based New Brunswick, New Jersey. Alternative locations include Raritan, New Jersey. Our Global Focus in Advanced Therapies Advanced therapy medicinal products (ATMPs), including CAR-T and viral vector-based treatments, represent a transformative approach to patient care. As a global organization, we strive to harmonize validation strategies, ensuring consistency, compliance, and innovation throughout our manufacturing network. The Process Validation Center of Excellence The CoE provides strategic leadership for validation activities and governance standards to drive accountability across partners. We define standard processes, drive harmonization, and enable technology adoption to ensure robust, validated processes that meet regulatory expectations and deliver life-changing therapies to patients worldwide. Role Summary The Senior Scientist serves as a key member of the global Life Cycle Management team, responsible for developing, implementing, and governing validation strategies across the Advanced Therapies network. This role focuses on global alignment, standardization of validation approaches, and strategic oversight of Tech Transfer, PPQ campaigns, CPV programs, and digital readiness. This role partners closely with regional MSAT, R&D, Quality, Regulatory, and Engineering teams to ensure consistent, compliant, and innovative validation practices globally. Operational Excellence & Governance 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. Cross-Functional Leadership & Communication 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. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) United States - Requisition Number: R-048421 Belgium - Requisition Number: R-049802 Ireland - Requisitions Number: R-049778 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Requirements

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
International travel to partner sites and global meetings, up to 20% of the time.
Flexibility to work remotely when not travelling.
Language requirements – fluency in English required; additional languages preferred.

Nice To Haves

Prior experience in cell culture or viral vector commercial manufacturing is highly desired.
Knowledge in statical process control and analytical data modeling.
Experience in digital solution implementation and deployment.
Knowledge in data management platforms and data governance

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.

Benefits

Employees are eligible for the following time off 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