Senior Manager, Engineering Technical, Lean Strategy and Compliance Services

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.

KNOWLEDGE AND SKILLS REQUIRED:

• BS in Science, Engineering, or technical related field.

• Five 5 years of experience in Engineering Department related matters in the biopharmaceutical industry.

• Knowledge of EOHSS, cGMP’s, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant.

• Timely and effective decision making, and timely conflicts resolution skills.

• Computer literate with the ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, etc.

• Ability to read and interpret layout drawings, mechanical, pneumatic and electrical blueprints, is preferred

• Fluently in English/Spanish (Oral and Written)

• Strong interpersonal relationship skills with subordinates, peers, management and clients.

• Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.

• In-depth knowledge in the design, installation, commissioning and validation/qualification of equipment/instruments as applied to pharmaceutical production environment.

• Experience with external and internal regulatory audits (DNRA, JCA, FDA, EMEA,  etc.)

• Good technical writing skills and ability to review SOPs and work instructions

• Self-motivated, creative and team work oriented.

• Self starter and good organizing and planning skills

• Strong knowledge and experience in statistical tools

• Strong presentation skills

• Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers’ at all organizational levels and disciplines in such a way to facilitate the engineering department work.

• Self-starter and able to plan and prioritize multiple complex activities simultaneously (i.e.: installation,  integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.

• Willing to work irregular hours, different shifts, weekends and holidays, when necessary

KEY RESPONSIBILITIES

• Owns the Engineering department Technical (Production and Facility Equipment), Lean Strategy and Compliance Services related to EOHSS and Sustainability Non-Capital projects, CAPA, Audits, Change Controls and Environmental Activities.   

• Including CAPAs, non capital projects and any improvements activities related to this program. Monitors the change process for system procedures and standards.

• Evaluates change proposals, coordinates change development, and implements change.

• Advises on and participates in the training of the EOHSS users.

• Establish a system to ensure work requests/orders are accurate and clear, the validity and accuracy of information and that the appropriate resources to set a preliminary priority are engaged.

• Measures and monitors backlog for adherence to site and SOP standards. Write deviations to document and investigate atypical events in the Engineering related to EOHSS and any other  Sustainability Non-Capital projects, CAPA, Audits, Change Controls and Environmental activities. 

• Lead investigations as necessary.

• Acknowledge, conducts and/or approve investigations for the engineering department activities. 

• Lead and / or develop Corrective Actions and Preventive Actions (CAPA) or Actions related to regulatory observations, internal audits or deviations.  Perform the EOHSS CAPA management of the Engineering department.

• Provides technical assistance and oversight to the Engineering Technical Services workflow management procedures and adherence to established KPIs.

• Supports readiness of the facility for Regulatory Inspection. 

• Leads and represents the engineering department during regulatory agencies inspections such as FDA, DNRA, JCA and Health Agency and/or during internal company audits.

• Support Engineering Department with EOHSS Agreements discussion and approvals.

• Collaborates with other departments such as Quality, EOHSS, Manufacturing Technology, Production and Planning and scheduling to ensure alignment of goals. 

• Prepares, submit and discuss reports of Engineering Department Technical Services areas status for trending and evaluation to the site management. Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.

• Prepares the Engineering Department  presentation and manage the action items from the monthly EOHSS Council meeting and presentations.

• Develops impact assessments related to Policies and Directives implementation.

• Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule.

• Support the Inspection Readiness Program.

• Provides support to Site Projects.

• Provides compliance oversight and verifying compliance with BMS Policies, guidelines and regulations

• Liaison for regulatory initiatives Creates, evaluates, follows up and approves GMP Change controls and EOHSS MOC for the Engineering Department, including interaction with corporate support areas.

• Enforces critical analytical thinking in the Change Control and Deviation management process.

• Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.

• Participates in Tier Meetings, department staff, planning and change control board meetings as required.

• Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities.

• Provides leadership and direction for the implementation of strategic projects aimed at fostering a Culture of Excellence and other strategic initiatives, (Engineering 6S program sustainability, Tiers Management System maintenance & sustainability, and the deployment of operational excellence tools) to increase capabilities and performance in collaboration with the site operational excellence team.

• Leverages operational excellence toolset using techniques to analyze core Engineering Operational areas influenced by process improvement, new systems infrastructure, and waste reduction.

• Participates actively in the preparation of the department budget and effectively manages company funds and actives.

• Creates business cases using operational excellence tools, coach, and manage operational excellence projects to ensure continuous process improvements and waste reduction with measurable financial results.

• Performs other duties as assigned, like assistance in supervision and technical support of other Engineering Department section like Production maintenance, Facility / Utility and Capital projects sections.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Manati - PR - US: $103,270 - $125,135


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/.
 

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 as “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

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 adastaffingsupport@bms.com. 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 TAEnablement@bms.com. 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.

R1603382 : Senior Manager, Engineering Technical, Lean Strategy and Compliance Services