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Job Details


Bristol-Meyers Squibb, Co.

Manager, Training & Instructional Design Specialist (R1552496-en-us)

Pharmaceuticals

All

Yearly

No

Manati, Puerto Rico, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

MAJOR DUTIES AND RESPONSIBILITIES:

Administers the Site Qualification and On the Job Training Program in terms of compliance with Corporate policies.

Become a subject matter expert (SME) in the assigned operating and/or support area (Sterile and Non-Sterile Operations, Warehouse, QC Laboratories, Engineering, etc.) in order to gain the ability to deliver training and provide knowledge transfer.

Develops trainers in the operating areas including (but not limited to) Warehouse, QC, Manufacturing, Engineering, Maintenance to coordinate training throughout the plant.

Actively builds collaborative relationships partnerships with all levels of the organization in the identification and implementation of learning solutions. Plans and co-facilitates classroom training sessions and learning labs focusing on a wide variety of topics.

Provide guidance, expertise and consulting to functional managers and SMEs in the assessment of training needs, the design of appropriate training, development, and implementation, and the measurement of training effectiveness.

Demonstrates initiative, teamwork, commitment and follow-through with all training initiatives.

Works independently and, if issues or problems are identified, works with Management to resolve.

May work on assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

Designs regulatory training processes (GMP) needed at the plant. Identifies and pursues opportunities to use technology to maximize and facilitate knowledge transfer.

Monitors effectiveness of knowledge transfer programs and makes needed corrections. Monitors and audits the areas of Qualification training programs (QC Laboratories, Warehouse, Manufacturing and Utilities).

Receives, evaluates Human Error Quality Events and recommends appropriate corrective and preventive actions (CAPA). Monitors areas (QC Laboratories, Warehouse, Manufacturing and Utilities environmental tests) specific qualification annual plans.

Provides support in creating and reviewing qualification skills modules. Harmonizes the site qualification training program with the Corporate Policies. Reviews Work Instruction Procedures for Operations area or for equipment to harmonize them with the process reality and operational experiences.

Identifies and updates operators Learning Plans for qualifications tasks to ensure a systematic approach and compliance.

Aligns the qualification training program needs with Manufacturing and Quality Control areas. Submits and approves DCA change requests and procedures.

Provides technical and regulatory trainings. Coordinates and delivers training sessions.

Works with the site areas to update training requirements specifically based on the needs of the Manufacturing and Supporting areas.

DECISION MAKING
  • Key decision making regarding curriculum / training contents, in WFT program definition / improvements
  • Significant influence in Safety Program design, on progression ladder structure, on competency development program.
  • Notifies immediate supervisor of any inconsistencies or violations to Company operation procedures and policies.
  • Job requires close attention to details for accuracy on manufacturing and operations process.
  • Any error not detected on time, could cause a regulatory impact.
  • The incumbent is expected to work independently to accomplish established goals/objectives. Incumbent participates in Staff meetings for status reports as required. Objectives and goals are set yearly with the respective accountability/expectations.

CONTACTS

  • Frequent interaction with area supervisors, and managerial levels is necessary to establish the proper approach for strategic decisions needed to assure the qualification training program compliance.
  • Continuous interaction with employees at all levels of the organization during training delivery and knowledge transfer.
  • Occasional interaction with training suppliers and Corporate team/management for initiatives related to training.
  • Occasional interaction with local and external regulations agencies.

KNOWLEDGE / SKILL

  • Bachelor’s Degree in Science (Microbiology, Chemistry, Engineering or Pharmacy), Instructional Design, Business Administration, Industrial Organizational Psychology or Education.
  • Five (5) years of experience in the technical training field within the pharmaceutical manufacturing industry or a related field with at least two (2) years of experience in a similar function within a parenteral manufacturing facility.
  • At least two (2) years of instructional design and curriculum development experience.
  • Strong understanding of adult learning theory and a variety of learning methodologies with experience in instructor-led, virtual classroom delivery and e-learning formats.
  • Working experience with the ADDIE model or other instructional design methodologies.
  • Knowledge and ability to develop training programs and materials.
  • Strong analytical, problem-solving, and decision-making capabilities
  • Strong knowledge in Root Cause evaluation associated to human error.
  • Knowledge of aseptic manufacturing processes such as: aseptic filling, cleaning and sterilization and sterile filtration.
  • Experience using a Learning Management System (LMS).
  • Experience working with highly automated manufacturing areas.
  • Knowledge of cGMP’s, Safety and Environmental regulations.
  • Excellent oral, interpersonal, and written communication skills.
  • Excellent Presentation/delivery training Skills.
  • Proficient knowledge of Computerized programs (Microsoft Office including Word, Power Point, Excel and etc.).
  • Knowledge of GMP’s, FDA Regulations, documentation practices and manufacturing process.
  • Experience working with manufacturing documents, change controls and regulatory.
  • Fully Bilingual (English and Spanish) written and oral.
  • Excellent interpersonal skills required.
  • Willing to work irregular hours, rotative shifts, weekends and holidays

WORKING CONDITIONS

  • Occasional exposure to hazardous chemicals during plant work.
  • Possibility of minimal or minor exposure to chemical substance due to visit to manufacturing/ exposure areas, or on emergency situation.
  • Required the use of minimum personal protective equipment (safety shoes, safety glasses, hard hat) but the use of special gowning as defined and required in the Manufacturing areas.
  • Frequently writing and use of keyboard

B. Travel required

  • Travel required – occasional travel is required for seminars and projects.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

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