Sr. Specialist, Process Automation

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.

3rd Shift 12 Hr Support (5:00 PM to 5:30 AM)

Accountable for providing automation support within the Sterile/Non Sterile Manufacturing, Facilities and Utilities areas and; for providing computer technology support to the Computerized Equipment at Production, Facilities and Utilities Areas. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

MAJOR DUTIES AND RESPONSIBILITIES

1. Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Production, Facilities and Utilities Areas.

a) Supports all equipment process control and automation systems assuring process control and automation systems operations are maintained considering plant policies, procedures and FDA regulations under cGMP’s and other regulations applicable.

b) Supports process integration for major computer system applications that impact the (Production, Facilities and Utilities) Areas.

c) Performs process equipment analysis and recommends improvements to existing processes through the use of state-of-the-art computer technology and participates proactively as a team member of implementation projects for new integrated business application and process automation, providing consulting advice in the use and management of technology.

d) Installs, configures, troubleshoots, and maintains process control and automation systems. These systems include, not limited to: PLCs, SCADAs/HMIs, microcontrollers, single loop controllers, DCS, interfaces and report development.

2. Provides user’s training and continuous support to assure proper use of the software applications following established operational procedures and user support during problem solving situations associated with systems implementation and; also assess and prepares development training in target areas in order to increase technician’s proficiency in current technology and assignments to support reliability program (e.g. FMEA/FMECA documents, root cause analysis, etc.)

3. Reviews computer related software applications or computer programs to ensure that plant standards are met and that programs are capable of being integrated with other software applications as required.

4. Troubleshoots and maintains process control and automation systems such as PLCs, SCADA, DCS, and Fourth generation languages for interfaces and reports development in the Manufacturing, Facilities and Utilities areas.

5. Evaluates, originates and closes change control documentation assuring the validated and compliance state of the environments and performs documentation of maintenance activities using Computer Maintenance Management System (CMMS) according to procedures.

6. Performs project management functions for the execution, implementation and start-up of process control and automation systems.

7. Evaluates workload and capacity of process control and automation systems to determine feasibility for expanding, upgrading or enhancing operations.

8. Reviews and tests programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level.

9. Performs changes to applications, configurations or programming to assure software works as expected before installing it in the user environment.

10. Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established due dates and; provides alternatives and problem solving initiatives during possible project delays or possible showstoppers.

11. Prepares or provides support in the preparation of procedures (e.g., Systems Life Cycle) and defines standards for software automation, system integration and defines the strategy for plant automation and process integration through an analysis and design/re-design of current systems and processes.

12. Prepares and/or reviews process control and automation systems related procedures, such as: Backup/Restore, Disaster Recovery and/or maintenance activities (i.e. PMs and troubleshooting guides).

13. Contacts hardware or software vendors (if applicable) to report problems and, coordinates and implements vendor recommendations when approved or accepted by the functional area owners.

14. Assures reported problems are solved by implementing corrective actions like (but not limited) users retraining, changes to existing SOPs, applying software fixes or hardware fixes, information resources colleagues recommendations, etc. These activities must comply with current applicable change control procedures.

15. Provides sound problem solving techniques to resolve issues and qualification problems.

16. Assists in the management of Capital Appropriation Requests (CAR’s), and timeline of process control and automation systems projects and implementation and/or initiatives.

DECISION MAKING

Describe the position's responsibility for taking action, making final decisions and developing recommendations. Limiting factors might include existing policies, laws, regulations, internal controls, etc.

Take key and timely decisions on Automation and Reliability maintenance activities that would have a direct impact in the Manufacturing and Facility Operations.

Decisions will require taking immediate actions, prioritizing, negotiation, independent judgment, resources allocation and development of future corrective actions to avoid recurrent events.

Delayed decisions may cause:
  • A potential loss of the batch and millions of dollars during a lyophilization process.
  • A potential loss of the batch and millions of dollars during a fill performed within an isolator or aseptic environment.
  • Additional manufacturing time, packaging rework, overtime and an increase in product cost.
  • Planning and Customer commitment delays, therefore, lost of confidence and reputation.
  • Integrity of the product could be at risk
  • Not developed recommendations will cause major exposure to regulatory and compliance citations.


B. Describe the nature of supervision received, the degree to which procedures, methods and goals are outlined by the supervisor, and the immediacy of supervision -

Will work under minimum supervision and will report in a daily manner to his/her supervisor daily events and situations beyond his/her control.

Notify immediate supervisor of any inconsistencies or violations to Company operation procedures and policies.

KNOWLEDGE/SKILL:
  • BS in Electrical, Computer, Mechanical Engineering, Electronics and or any other Science related field.
  • Two (2) years of experience in process automation in a pharmaceutical manufacturing environment with a general knowledge in operations or manufacturing processes.
  • Proficient knowledge of FDA regulatory requirements, including 21 CFR Part 11.
  • Broad knowledge of cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
  • Ability to troubleshoot problems for highly technical equipment.
  • Knowledge of pharmaceutical business processes and equipment.
  • Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
  • Proven knowledge in process control and automation systems used in the pharmaceutical industry (not limited to): PLCs, SCADAs/HMIs, microcontrollers, single loop controllers, DCS, interfaces and report development.
  • Ability to manage and operate computer software packages used for data acquisition systems and PLC programming.
  • Strong Databases and networking knowledge’s.
  • Able to read, interpret, and understands electrical/mechanical drawings, P&IDs and electrical one-line diagrams.
  • Good technical writing skills and ability to review SOPs and work instructions.
  • Flexible and responsible.
  • Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data.
  • 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 validation/qualification work.
  • 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, rotative shifts, weekends and holidays, when necessary.
  • Self-starter and well organized.
  • Ability to keep work pace and/or meet deadlines.

Ability to exercise good judgment.

WORKING CONDITIONS:

A. Describe exposure to any hazards/disagreeable in the work environment:
  • Intermittent exposure to potential hazardous conditions.
  • Occasional exposure to extreme temperature and excessive noise
  • Frequent walking (30%) and occasionally sitting (30%) and standing (30%)
  • Occasionally Light material handling (up to 16-20lbs)
  • Frequent writing and use of keyboard
  • Minimum personal protective equipment (safety shoes, safety glasses, hard hat) required
  • Special gowning as defined and required in the Manufacturing areas.


B. Travel required (describe nature and frequency):
  • Some travel required to perform manufacturing equipment/systems inspection, acceptance and/or technical training

C. Overnight absences requires (per typical month):
  • Average absence from home of three to five nights per month not due to shift work


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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility 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.

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