Senior Manager, Engineering Technical, Lean Strategy and Compliance Services

Working with UsChallenging. 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 preferredFluently 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 instructionsSelf-motivated, creative and team work oriented.Self starter and good organizing and planning skillsStrong knowledge and experience in statistical toolsStrong presentation skillsAble 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 necessaryKEY RESPONSIBILITIESOwns 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 regulationsLiaison 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