Bristol-Myers Squibb Company

Automation Specialist

Location
Manati, PR, United States
Posted
Jul 06, 2019
Ref
R1515791
Required Education
Bachelors Degree
Position Type
Full time
3rd Shift Support - 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.

RESPONSIBILITIES
  • Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Production, Facilities and Utilities Areas.
    • 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.
    • Supports process integration for major computer system applications that impact the (Production, Facilities and Utilities) Areas.
    • 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.
    • 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.
  • 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.)
  • 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.
  • 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.
  • 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.
  • Performs project management functions for the execution, implementation and start-up of process control and automation systems.
  • Evaluates workload and capacity of process control and automation systems to determine feasibility for expanding, upgrading or enhancing operations.
  • 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.
  • Performs changes to applications, configurations or programming to assure software works as expected before installing it in the user environment.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • Provides sound problem solving techniques to resolve issues and qualification problems.
  • Assists in the management of Capital Appropriation Requests (CAR's), and timeline of process control and automation systems projects and implementation and/or initiatives.


QUALIFICATIONS
  • 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.


DECISION MAKING

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.


Nature of supervision received
  • 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.


CONTACTS
  • Inside the Company - Contacts with site and/or regional management, corporate and local manufacturing plant managers, Department Managers, Supervisors, Technical Services group, Product Transfer, Reliability Engineer and Peers, and other Bristol-Myers Squibb personnel.
  • External Contact - with suppliers of hardware, software and services to obtain quotations, ordering parts and repairs. Local (PR) and external (USA) consultants and suppliers. Federal agencies such as Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), Pharmaceuticals Manufacturers Association and others to stay updated on current information


WORKING CONDITIONS

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.


Travel required
  • Some travel required to perform manufacturing equipment/systems inspection, acceptance and/or technical training


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