Senior Manager, Engineering Technical, Lean Strategy and Compliance Services

Bristol Myers Squibb•Manatí, PR

4d•$103,270 - $125,135•Onsite

About The Position

Bristol Myers Squibb is seeking a Senior Manager, Engineering Technical, Lean Strategy and Compliance Services. This role is crucial for optimizing production lines and driving breakthroughs in cell therapy, ultimately transforming patient lives. The position offers opportunities for growth and development within high-achieving teams, with a focus on work-life balance and a wide array of competitive benefits and programs. The company culture emphasizes innovation, collaboration, and a commitment to scientific advancement.

Requirements

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.
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.

Nice To Haves

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

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.
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.
Establishes 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.
Writes 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.
Leads investigations as necessary, acknowledges, conducts and/or approves investigations for the engineering department activities.
Leads and / or develops Corrective Actions and Preventive Actions (CAPA) or Actions related to regulatory observations, internal audits or deviations.
Performs 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.
Supports 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, submits and discusses 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 manages 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-established schedule.
Supports the Inspection Readiness Program.
Provides support to Site Projects.
Provides compliance oversight and verifies compliance with BMS Policies, guidelines and regulations.
Acts as 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 activities.
Creates business cases using operational excellence tools, coaches, and manages 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 sections like Production maintenance, Facility / Utility and Capital projects sections.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval).
11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
160 hours annual paid vacation for new hires with manager approval (Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees).
11 national holidays, and 3 optional holidays (Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees).
Unlimited paid sick time (based on eligibility).
Up to 2 paid volunteer days per year (based on eligibility).
Summer hours flexibility (based on eligibility).
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.