Raritan, New Jersey, United States of America, United States of America
Onsite
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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Raritan, New Jersey, United States of AmericaJob 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 Sr Manager Digital Integrity C&Q and Manufacturing Control Systems to join our team in Raritan, NJ.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered
Job Summary
This role is responsible for leading a integrated compliance, lifecycle, and validation program for GMP-relevant equipment, facilities, utilities, and computerized manufacturing systems. The position combines responsibility for data integrity and computerized system compliance, commissioning and qualification strategy and execution, and lifecycle reliability of manufacturing control systems. The role ensures systems, assets, and associated procedures remain qualified, validated, reliable, secure, and inspection-ready throughout their lifecycle while supporting business continuity, product quality, and regulatory compliance. This individual partners closely with Quality, Manufacturing, Engineering, Facilities, Automation, Validation, Digital/IT, and system owners to define standards, implement risk-based plans, drive remediation and continuous improvement, and sustain compliant operations across the site.
Key Responsibilities
Lead multi-site strategy and execution for data integrity compliance, commissioning and qualification, requalification, computerized system validation, and lifecycle reliability of manufacturing control systems supporting GMP operations.
Perform and oversee risk-based assessments of equipment, facilities, utilities, and computerized systems against applicable regulatory and company requirements, including Annex 11, 21 CFR Part 11, ALCOA+ principles, and current GMP validation expectations.
Own or govern key lifecycle programs for manufacturing control systems, including system inventory, criticality ranking, obsolescence management, patching and upgrade strategy, backup and restore, disaster recovery, periodic review, and retirement planning.
Lead commissioning, qualification, requalification, and validation activities for new and existing assets, including impact assessments, validation plans, IQ, OQ, PQ, CSV deliverables, and associated testing strategies.
Provide oversight for computerized system validation deliverables such as URS, functional and design specifications, FAT, SAT, integration testing, functional testing, risk assessments, traceability, and validation summary documentation.
Define and maintain procedures and standards for change control, configuration management, access management, audit trails, electronic signatures, backup verification, restore testing, record retention, and governance of GxP computerized systems.
Develop and execute risk-based remediation and mitigation plans to address compliance gaps, validation issues, lifecycle risks, and reliability concerns, with clear owners, timelines, priorities, and effectiveness measures.
Establish and maintain trackers, metrics, and governance routines to monitor progress across C&Q, requalification, CSV, data integrity, and control system lifecycle activities, and escalate risks and overdue actions to leadership as appropriate.
Ensure that manufacturing control systems remain reliable, secure, validated, and fit for intended use, including PLC, SCADA, HMI, historian, recipe management, alarm management, and related automation platform elements.
Lead or support upgrades, migrations, and modernization initiatives for equipment and computerized systems while preserving validated state, required retained data, audit trail continuity, and operational continuity.
Own or support the Validation Master Plan and related site validation governance processes to ensure alignment across equipment, facilities, utilities, automation, and computerized systems.
Partner with Quality, Manufacturing, Engineering, Facilities, Automation, Digital/IT, Validation, and external vendors to ensure compliant implementation, effective issue resolution, and sustainable lifecycle management practices.
Support investigations, deviations, CAPAs, audit responses, and health authority inspections related to qualified state, computerized system compliance, automation failures, backup events, or data integrity concerns.
Ensure documentation is complete, current, and inspection-ready, including validation packages, configuration records, network and architecture diagrams, backup records, disaster recovery plans, SOPs, work instructions, and periodic review records.
Drive continuous improvement and standardization of site processes for qualification, validation, lifecycle planning, and compliance management to improve efficiency, maintainability, and inspection readiness.
Provide technical leadership, coaching, and subject matter expertise across CQV, computerized systems, and manufacturing control system lifecycle management.
Qualifications
Education
Minimum Bachelor’s degree in Engineering, Science, Automation, Computer Science, Information Systems, or a related technical discipline is required, advanced degree preferred.
Experience and Skills
Required
Minimum 8 years of a relevant work experience
Significant experience in a regulated pharmaceutical, biotechnology, medical device, or advanced therapy manufacturing environment with direct responsibility for commissioning and qualification, validation, computerized systems, automation, or data integrity compliance.
Strong solid understanding of current GMP requirements and validation principles applicable to equipment, facilities, utilities, and computerized systems, including Annex 11, FDA 21 CFR Part 11, data integrity expectations, and risk-based lifecycle practices aligned with GAMP 5.
Demonstrated experience leading gap assessments, impact assessments, risk assessments, remediation planning, and compliance tracking for GxP systems and qualified assets.
Experience developing and completing qualification and validation documentation, including VMPs, URS, FS, DS, FAT, SAT, IQ, OQ, PQ, requalification, and validation summary results.
Experience managing system lifecycle activities such as upgrades, patching, backup and restore, disaster recovery, obsolescence planning, and retirement of GMP-relevant computerized systems.
Ability to interpret regulatory expectations and translate them into practical technical and procedural controls.
Strong project leadership, multi-functional teamwork, and interpersonal skills, with the ability to influence.
Experience supporting internal audits, external audits, and health authority inspections, including investigation, deviation, and CAPA support.
Preferred
Experience with manufacturing automation and data platforms such as DeltaV, Rockwell, Siemens, Wonderware, PI Historian, MES, SAP, TrackWise, truVault, or comparable systems.
Experience in biologics, cell therapy, gene therapy, aseptic processing, or other highly regulated manufacturing environments.
Familiarity with industrial control system infrastructure, cybersecurity sustainment, and networked GMP environments.
Experience building lifecycle inventories, obsolescence registers, capital plans, and site standards for backup, recovery, and modernization.
People leadership or team management experience, either direct or indirect.
Project management certification or equivalent proven program leadership experience.
Strong technical writing skills and proven ability to prepare inspection-ready documentation and executive-ready status reporting.
Other
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation.
Required Skills:
Preferred Skills:
Coaching, Collaboration, Controls Compliance, Fact-Based Decision Making, Financial Competence, ISO 9001, Lean Supply Chain Management, Non-Conformance Reporting (NCR), Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Schematic Design, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Want to know if this job is worth applying to?
