Johnson & Johnson
Manager Facilities Management (FM) Calibration Compliance
Johnson & Johnson, Gurabo, Gurabo, us, 00778
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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 People Leader
All Job Posting Locations Brussels, Brussels-Capital Region, Belgium; Gurabo, Puerto Rico; United States of America; Latina; Italy; Little Island, Cork, Ireland; New Brunswick, New Jersey, United States of America
Job Description Johnson & Johnson is recruiting for a Manager Facilities Management (FM) Calibration Compliance. The role can be located within US, Puerto Rico, or Europe.
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. 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
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 & Puerto Rico – Requisition Number: R-036121
Europe – Requisition Number: R-039736
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Position Overview The Manager, FM Calibration Compliance is responsible for ensuring that facilities adhere to the highest standards of calibration practices in line with cGMP regulations. The role drives the development and implementation of comprehensive calibration programs, leading, maintaining, and overseeing the calibration process within Facilities Management scope to enhance operational capabilities and ensure compliance. The manager collaborates closely with SMEs and partners across FM and the CoE to identify calibration needs, mitigate risks, promote operational reliability, and lead all aspects of calibration methodologies. This role is critical to maintaining audit readiness, ensuring robust traceability of calibration records, and supporting the broader organizational effort to build skills, embed best practices, and sustain operational excellence.
The Candidate For This Role Will Have
Strong technical background in 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, enabling collaboration across regions, supporting audits, and promoting a culture of compliance and operational excellence.
Key Relationships 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 to ensure effective implementation of the calibration program across all manufacturing facilities.
Establish, lead, and maintain calibration programs to ensure compliance with cGMP regulations and industry standards.
Identify calibration‑related risks that could affect product quality, safety, or compliance, and develop strategies to mitigate these risks.
Develop and implement procedures for handling calibration deviations and investigations.
Establish a robust system for managing calibration records, ensuring audit readiness and traceability.
Define and implement corrective and preventive actions related to calibration issues.
Conduct regular audits and compliance reviews to verify adherence to internal standards and regulatory requirements.
Lead calibration deviation management and facilitate investigations, including audits, to identify root causes.
Analyze calibration trends and lessons learned for continuous improvement opportunities.
Share insights and recommendations to optimize calibration practices 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 calibration 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 programs at a global level, including establishing, maintaining, and auditing calibration 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 in calibration 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 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.) preferred.
Other
English proficiency (oral & written) is required.
This role may require 30% 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/Preferred Skills
Budget Management
Developing Others
EHS Compliance
Facility Management
Fact‑Based Decision Making
Inclusive Leadership
Leadership
Manufacturing Compliance
Performance Measurement
Predictive Maintenance
Problem Management
Problem Solving
Process Optimization
Repair Management
Resource Allocation
Standard Operating Procedure (SOP)
Team Management
Salary The anticipated base pay range for this position is $100,000 – $173,500. For the Bay Area, the salary for this position is $197,800.
Benefits
Employees and/or eligible dependents may be eligible to participate in the following company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time‑off benefits: vacation – up to 120 hours per calendar year; sick time – up to 40 hours per calendar year (up to 56 hours for Washington state residents); holiday pay, including floating holidays – up to 13 days per calendar year; personal and family time – up to 40 hours per calendar year.
Additional information can be found through the link below: https://www.careers.jnj.com/employee-benefits. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Referrals increase your chances of interviewing at Johnson & Johnson by 2x
#J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features.
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 People Leader
All Job Posting Locations Brussels, Brussels-Capital Region, Belgium; Gurabo, Puerto Rico; United States of America; Latina; Italy; Little Island, Cork, Ireland; New Brunswick, New Jersey, United States of America
Job Description Johnson & Johnson is recruiting for a Manager Facilities Management (FM) Calibration Compliance. The role can be located within US, Puerto Rico, or Europe.
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. 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
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 & Puerto Rico – Requisition Number: R-036121
Europe – Requisition Number: R-039736
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Position Overview The Manager, FM Calibration Compliance is responsible for ensuring that facilities adhere to the highest standards of calibration practices in line with cGMP regulations. The role drives the development and implementation of comprehensive calibration programs, leading, maintaining, and overseeing the calibration process within Facilities Management scope to enhance operational capabilities and ensure compliance. The manager collaborates closely with SMEs and partners across FM and the CoE to identify calibration needs, mitigate risks, promote operational reliability, and lead all aspects of calibration methodologies. This role is critical to maintaining audit readiness, ensuring robust traceability of calibration records, and supporting the broader organizational effort to build skills, embed best practices, and sustain operational excellence.
The Candidate For This Role Will Have
Strong technical background in 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, enabling collaboration across regions, supporting audits, and promoting a culture of compliance and operational excellence.
Key Relationships 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 to ensure effective implementation of the calibration program across all manufacturing facilities.
Establish, lead, and maintain calibration programs to ensure compliance with cGMP regulations and industry standards.
Identify calibration‑related risks that could affect product quality, safety, or compliance, and develop strategies to mitigate these risks.
Develop and implement procedures for handling calibration deviations and investigations.
Establish a robust system for managing calibration records, ensuring audit readiness and traceability.
Define and implement corrective and preventive actions related to calibration issues.
Conduct regular audits and compliance reviews to verify adherence to internal standards and regulatory requirements.
Lead calibration deviation management and facilitate investigations, including audits, to identify root causes.
Analyze calibration trends and lessons learned for continuous improvement opportunities.
Share insights and recommendations to optimize calibration practices 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 calibration 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 programs at a global level, including establishing, maintaining, and auditing calibration 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 in calibration 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 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.) preferred.
Other
English proficiency (oral & written) is required.
This role may require 30% 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/Preferred Skills
Budget Management
Developing Others
EHS Compliance
Facility Management
Fact‑Based Decision Making
Inclusive Leadership
Leadership
Manufacturing Compliance
Performance Measurement
Predictive Maintenance
Problem Management
Problem Solving
Process Optimization
Repair Management
Resource Allocation
Standard Operating Procedure (SOP)
Team Management
Salary The anticipated base pay range for this position is $100,000 – $173,500. For the Bay Area, the salary for this position is $197,800.
Benefits
Employees and/or eligible dependents may be eligible to participate in the following company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time‑off benefits: vacation – up to 120 hours per calendar year; sick time – up to 40 hours per calendar year (up to 56 hours for Washington state residents); holiday pay, including floating holidays – up to 13 days per calendar year; personal and family time – up to 40 hours per calendar year.
Additional information can be found through the link below: https://www.careers.jnj.com/employee-benefits. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Referrals increase your chances of interviewing at Johnson & Johnson by 2x
#J-18808-Ljbffr