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:

Environmental Health, Safety (EH&S) and Facilities Services (FS)

Job Sub Function:

Facilities Repair & Maintenance

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

Johnson and Johnson is recruiting for a(n) Manager Facilities Management (FM) Compliance. The role will be located in Gurabo, Puerto Rico. Remote work options may be considered on a case-by-case basis and if approved by the company.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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

The Manager, Facilities Management (FM) Compliance, is responsible for ensuring that Facilities adheres to the highest standards of Facilities Management practices, in line with cGMP regulations. Plays a vital role in driving the development and implementation of comprehensive programs, leading, maintaining and overseeing processes within Facilities Management scope to enhance operational capabilities and ensure compliance. This role collaborates closely with SMEs and partners across FM and the CoE to identify compliance needs, mitigate risks associated with Facilities Management, and promote operational reliability.

This role is critical to maintaining audit readiness and ensuring robust traceability of records, which are vital for regulatory compliance. The role ensures that calibration/maintenance programs are continuously reviewed for relevance and effectiveness. Acting as a key enabler in encouraging a learning culture, the role supports the broader organizational effort to build skills, embed best practices, and sustain operational excellence across FM.

The candidate for this role will have:

• Strong technical background in facilities management including calibration management, instrumentation, and quality systems, with extensive experience in regulated environments such as pharmaceuticals, biotech, or manufacturing.
• In depth knowledge of cGMP, industry standards, and risk mitigation strategies related to calibration programs.
• Proven record of leadership in handling compliance processes with ability to provide global guidance, influence cross-functional teams, and act as a trusted advisor on calibration compliance.
• Excellent analytical and problem-solving skills, with a track record of identifying compliance gaps, implementing corrective actions, and driving continuous risk reduction.
• Strong communication and stakeholder engagement skills are critical, enabling them to collaborate effectively across regions, support audits, and promote a culture of compliance and operational excellence.

Key relationships include (but not limited to) FM leadership & Regional teams, Quality, Compliance & Regulatory teams, IT, Supplier/Service Providers, Training & Development, Asset Management, Risk Management & Validation, Manufacturing & Operations, Regulatory Authorities & Industry Bodies.

Key Responsibilities:

• Act as the calibration SME within the Facilities Management Center of Excellence (CoE) to ensure calibration program effectively implemented across all manufacturing facilities.
• Establish, lead and maintain facilities management programs to ensure compliance with cGMP regulations and industry standards.
• Identify risks that could affect product quality, safety, or compliance, and develop strategies to mitigate these risks.
• Develop and implement procedures for handling deviations and investigations.
• Establish a robust system for managing FM records, ensuring audit readiness and traceability.
• Define and implement corrective and preventative actions related to facilities management including calibration issues.
• Conduct regular audits and compliance reviews to verify adherence to internal standards and regulatory requirements.
• Lead deviation management and facilitate investigations, including audits, to identify root causes.
• Analyze trends and lessons learned for continuous improvement opportunities.
• Share insights and recommendations to optimize facilities management processes and risk mitigation.
• Actively support and advise facilities on calibration-related issues to maintain high standards of equipment reliability.
• Monitor calibration processes for efficiency and accuracy and implement process improvements as needed.
• Educate personnel on facilities requirements, procedures, and the importance of compliance.

Qualifications

Education:

• Bachelor’s or equivalent degree in Science, Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical field.

Experience and Skills:

Required:

• Minimum of 6-8 years of hands-on experience in calibration management, instrumentation, or quality assurance within regulated industries such as Pharmaceuticals, Biotech, or Medical Devices.
• Consistent track record of leading calibration / maintenance programs at a global level, including establishing, maintaining, and auditing processes.
• Experience with Digital & Automated Calibration Systems: Familiarity with calibration management software, CMMS platforms, or automated calibration tools to enhance compliance and efficiency.
• Demonstrated expertise in cGMP, regulatory standards, and risk mitigation related to calibration and equipment reliability.
• Deep understanding of industry-specific standards such as FDA regulations, EMA guidelines, and international calibration standards (e.g., ISO 17025, ANSI/NCSL Z540).
• Experience acting as a Subject Matter Expert (SME) in calibration / maintenance compliance, supporting audits, and implementing continuous improvement initiatives.
• Ability to analyze learning metrics, assess ROI, and continuously improve programs based on data insights.
• Prior leadership experience leading teams or cross-functional projects related to calibration or quality systems.
• Consistent track record to work effectively across multiple regions, cultures, and functions, promoting a unified approach to calibration compliance.
• Experience leading calibration-related projects, process improvement initiatives, or system implementations within a regulated environment.
• Experience developing training programs or mentoring teams to elevate calibration / maintenance practices and compliance awareness organization wide.
• Skilled in conducting risk assessments, root cause analysis, and implementing corrective and preventive actions (CAPA).
• Demonstrated success in leading change initiatives, process optimization, and driving a culture of compliance and operational excellence.
• Strong organizational skills to run multiple initiatives and timelines.
• Outstanding interpersonal skills for stakeholder engagement, presentations, and influence at senior levels.

Preferred:

• Advanced certifications such as ISO 17025, GMP Professional, or Calibration Technician certifications are highly desirable.
• Professional certifications (e.g., PMP, Lean, Six Sigma, etc.)

Other:

•  English proficiency (oral & written) is required.
• This role may require 30% of domestic or international travel.

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 resource.

 

 

Required Skills:

 

 

Preferred Skills:

Business Valuations, Data Savvy, Facility Management, Fact-Based Decision Making, Manufacturing Compliance, Performance Measurement, Predictive Maintenance, Problem Management, Problem Solving, Process Improvements, Process Optimization, Program Management, Repair Management, Technical Credibility, Training People