Manager, Compliance Facility Utility and General Maintenance

Bristol Myers Squibb•Manatí, PR

1d•$76,110 - $92,226•Onsite

About The Position

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.

Requirements

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.

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.

Benefits

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.