Manager, Compliance Facility Utility and General Maintenance

Bristol Myers Squibb; Manatí (PR); On-site; USD 76,000 - 92,000; Full time

Benefits offered by this job

Health Coverage

401(k) Plan

Paid Time Off

Life Insurance

Employee Assistance Program

Wellbeing Programs

Job summary

Bristol Myers Squibb in Manatí, Puerto Rico, is seeking a compliance-focused engineer to manage deviation records, CAPAs, and regulatory readiness for the manufacturing and engineering teams.

Role requires GMP/FDA/EU knowledge, strong writing and analytical skills, and bilingual Spanish/English. On-site position with comprehensive benefits and growth opportunities within a global biopharma leader.

Qualifications

• Bachelor degree in Engineering or technical field preferred.
• Five years of experience in Quality Unit and/or Engineering in biologics/pharmaceuticals.
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Strong knowledge of GMP, FDA, EU and EHS regulations.
• Expert in interpretation and application of regulations.
• Self-motivated, creative and team oriented.
• Excellent interpersonal and written communication skills.
• Strong knowledge of computer systems (MS Office, AI Copilot, Infinity) and tracking systems.
• Experience with statistical tools and data analysis.
• Strong presenting skills and good judgment.
• Ability to work within constrained time frames.

Responsibilities

• Initiates, documents, and supports deviation records and supplemental reports.
• Acknowledge and conducts investigations and deviations supplementals for facilities, utilities and maintenance.
• Supports readiness of the facility for regulatory inspection and represents maintenance during inspections.
• Supports maintenance and calibrations quality agreements discussions and approvals.
• Collaborates with Quality, EHS, Manufacturing Tech, Production, and Planning to align goals.
• Develops and implements departmental procedures and forms in line with GMP.
• Ensures site compliance with corporate systems and guidelines.
• Supports the site Quality Risk Management program in multidisciplinary teams.
• Documents impact assessments for corporate policies and directives.
• Supports the Site Inspection Readiness Program for audits.
• Provides compliance oversight for site projects and regulatory requirements.
• Supports compliance initiatives including inspections and follow-up activities.
• Maintains Records Retention Program for Engineering Dept.
• Manages change controls for the Manatí site in coordination with Corporate.
• Applies risk-based decisions in change control and deviation management.
• Participates in governance and planning meetings as required.
• Maintains communication with stakeholders to meet compliance expectations.

Skills

GMP Compliance

FDA/EU/EHS Knowledge

Technical Writing

Statistical Tools

Presentation Skills

Interpersonal Skills

Bilingual Spanish/English

Time Management

Education

Bachelor's degree in Engineering or technical field

Tools

Microsoft Office

AI Copilot

Infinity Tracking System

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Schedule- 8am-430pm.

Major Duties And Responsibilities

• Initiates, documents, and supports deviation records and supplemental reports to investigate atypical events within the Engineering organization, including leading investigations and deviation supplementals as required.
• Acknowledge and conducts investigations and deviations supplementals for facilities, utilities and/or maintenance deviations and supplementals. Accountable for Corrective Actions and Preventive Actions (CAPA) or actions related to regulatory observations, internal audits or deviations within the engineering department.
• Supports readiness of the facility for regulatory inspection. Represents the maintenance department during regulatory agency inspections such as FDA / EMEA and/or during internal company audits.
• Support maintenance and calibrations quality agreements discussion and approvals.
• Collaborates with cross‑functional partners, including Quality, EHS, Manufacturing Technology, Production, and Planning and Scheduling, to ensure alignment of objectives and compliance with site and organizational goals.
• Develops, reviews, approves, and implements departmental procedures and forms to ensure alignment with current practices, evolving GMP expectations, and established periodic review requirements.
• Ensures site compliance with corporate systems through the evaluation, implementation, and enforcement of company policies, standards, and guidelines.
• Supports the site Quality Risk Management program through participation in multidisciplinary teams and risk‑based decision‑making activities.
• Develops and documents impact assessments related to the implementation of corporate policies and directives, and ensures timely execution in accordance with established implementation schedules.
• Supports the site Inspection Readiness Program to ensure continuous preparedness for regulatory and internal audits.
• Provides compliance support to site‑level projects, ensuring alignment with applicable quality systems, regulatory requirements, and engineering standards.
• Provides compliance oversight and verifying compliance with BMS and WWQ&C Policies and Guidelines and site cGMP compliance policies and procedures are addressed.
• Supports regulatory inspections and compliance initiatives, including preparation, execution support, and follow‑up activities.
• Supports the Engineering Department Records Retention Program in accordance with corporate policies and regulatory requirements.
• Initiates, evaluates, reviews, approves, and follows up on change controls for the Manatí site, including coordination and alignment with corporate support functions.
• Applies and reinforces critical and analytical thinking throughout the change control and deviation management processes to ensure compliant, risk‑based decisions.
• Participates in tiered governance meetings, departmental staff meetings, planning forums, and change control board meetings as required.
• Maintains effective communication with internal and external stakeholders to ensure compliance expectations are met and assigned activities are completed in a timely manner.
• Perform and/or support other duties related to site compliance as required as per business need.

Knowledge & Skill Required

• Bachelor degree in Engineering or technical field science preferred.
• Five (5) years of experience in Quality Unit and/or Engineering in the biologics / pharmaceutical industry.
• Fully Bilingual (Spanish/English) communication skills, both written and verbal are required.
• Strong knowledge of relevant GMP, FDA, EU and EHS regulations.
• Expert in the interpretation and application of regulations according with the intended use.
• Self-motivated, creative and team work oriented.
• Excellent interpersonal skills and the ability to interact with people at all levels.
• Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
• Excellent knowledge of computer systems (Microsoft Office, AI Copilot, etc.) and tracking systems like Infinity and others.
• Strong knowledge and experience in statistical tools
• Strong presentation skills
• Able to exercise good judgment
• Ability to work within constraint time frames.
• Sense of urgency and analytical thinking are some of the critical competencies required for this position.
• Available to support a 24/7 operation any day of the week, including holidays.

Compensation Overview

Manati - PR - US: $76,110 - $92,226

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefits

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits Include

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring a “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Responsibilities

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1605579 : Manager, Compliance Facility Utility and General Maintenance