Calibration Supervisor, Cell Therapy – Bristol Myers Squibb – Warren, MI

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.

PURPOSE AND SCOPE OF POSITION:

The Calibration Supervisor is responsible for maintaining the functionality of the metrology department. This role has direct supervision over the calibration technicians operating at the site. This includes execution, review and approval of calibration work in the field and within the automated maintenance program. The Calibration Supervisor ensures that all the instrumentation and calibrations standards are properly maintained. The role also writes and supports deviations and investigations related the instrument failures.

The overall role is to maintain the integrity of the metrology program and ensure compliance to the BMS calibration program.

DUTIES AND RESPONSIBILITIES

General Roles

Working under minimal direction and guidance and be self-motivated, responsibilities shall include but not be limited to the following;

• Respond to Customer requests in a professional and timely manner.
• Respond in accordance to cGMP policies and procedures.
• Perform routine calibrations and controls troubleshooting
• Assist in troubleshooting and emergency situations.
• Complete necessary paperwork, i.e., Logbooks, Work Orders, Calibration Documentation in accordance with cGMP good documentation practices.
• Use various testing devices and standards related to calibration services.
• Demonstrate skill and care in the use of tools and materials used within calibration trades
• Perform all work in accordance with established safety procedures.
• Train colleagues as necessary.
• Work with internal and external partners. Provide cGMP oversight of external vendors to ensure they are operating within the cGMP policies and procedures of the area
• Other duties as assigned.

Calibration Technical Requirements

The candidate must have experience in the following:

• Perform routine instrument calibrations
• Inspect, maintain, test, troubleshoot, adjust, repair and/or replace instrumentation associated with systems identified in the Main Responsibilities section above.
• Must be competent in working in the electronic CMMS to track scheduled work and execute calibrations electronically.
• Must be competent in working in BMS/BEMS (Building Automation Systems) to support calibrations
• Must be proficient with Digital Controls, and/or pneumatics, plus other functional components of differing systems.
• Must be capable to provide diagnostic feedback to support deviations and investigations to support root cause analysis and corrective actions.
• Must be able to provide feedback on field calibrations to support continuous improvement of the calibration program.

Supervisor & Technical Administrative Requirements

• Provide daily oversight and direction to the Calibration Technicians
• Coordinate routine and demand calibrations with the Business Area Owners and the Facility Planners
• Review all executed calibrations within the CMMS or paper-based forms
• Identify OOT and escalate notification according to Celgene’s policies.
• Initiates deviations as they relate to calibration OOT or non-conformance conditions. Provide necessary investigations to support root cause analysis.
• Provide supporting data to report OOT and required investigations and CAPAs
• Assists in managing calibration standards required to support Celgene’s Calibration Program
• Conduct instrument evaluations and complete Instrument Data Forms to input new or revise instrumentation
• Assist in instrumentation criticality assessments
• Assist in creating new calibration procedures and providing input on existing for periodic reviews
• Initiate the necessary change controls and impact assessments to manage the replacement of instruments associated with GMP equipment.
• Provides oversight, support and direction to outside contracted calibration and controls service providers.
• Provide oversight of critical spare parts and inventory as they relate to instrumentation and controls
• Provides oversight of GMP training curriculum for internal technicians and external vendors.
• Manages 24/7 calibration technician response to critical equipment and alarms associated with IMTE
• Promotes and provides excellent customer service and support.

  Regularly reviews, prioritizes, coordinates and promptly responds to work orders and service requests.

  Provides technical support and guidance on instrument/controls-related issues. Interfaces with customers to ensure all expectations are being met

  Maintains a positive relationship with all the members of the Facilities department and our site customers while promoting a positive team environment

• Promotes and maintains compliance with corporate, safety, security and regulatory policies.

  Maintains all assigned Corporate, Facilities, GMP and EHS training as required

  Adheres to all safety procedures and hazard communication; updates and maintains applicable safety data sheets

  Ensures work areas in a clean, safe and organized state including all work rooms and storage areas.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Be proficient in cGMP guidelines in accordance with company policy and procedures. Provide direct oversite of technicians and external vendors to ensure compliance.
• Complete and review documentation associated with calibration work orders to ensure cGMP good documentation practices and change control procedures are being followed
• Expert knowledge of instrumentation.
• Expert written and verbal communication skills.
• Outstanding customer service skills.
• High proficiency in Microsoft Word, Excel and Outlook.
• High proficiency in CMMS, direct BMRAM experience preferred but not necessary
• Ability to solve basic technical problems.
• Ability to meet schedules and timelines.
• Strong interpersonal skills.
• Ability to read and comprehend blueprints, drawings, schematics, specifications, codes etc.
• Basic skills in electrical power and control wiring, instrumentation and data acquisition.
• Ability to adhere to Electrical Codes.

EDUCATION AND EXPERIENCE (As Applicable)

• Minimum of 5 years in Pharmaceutical Industry.
• Minimum of 5 years in a calibration technician or similar technical role.
• Minimum of 2 years in a supervisory role.
• Technical certification in instrumentation and/or Associates degree in Engineering.

WORKING CONDITIONS:

PHYSICAL /MENTAL DEMANDS:

• Work required in and around laboratory and regulated environments.
• Working in and around chemicals and potent compounds.
• Working in and around confined spaces. Certifications required
• Ability to lift greater than 50 lbs.
• Ability to perform on elevated work platforms.
• This position requires regular medical surveillance and will require incumbent to wear a respirator or gown.
• Ability to work a minimum of a 40 hours work week.
• Ability to work Rotating Shift as needed as well as Emergency, Overtime, and weekend shifts.
• Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
• Ability to work safely in an environment with exposure to high temperatures / pressure steam, compressed gasses, various noise levels, and high voltage energy supplies.
• Ability to sit, stand and move within workspace for extended periods.
• Occasional stooping, bending, stretching and lifting greater than 50lbs may be required.
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling.

ENVIRONMENTAL CONDITIONS:

• Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
• Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
• Environment may include working at heights, in cold temperatures, and/or constricted spaces
• Ability to work safely when working alone or working with others.
• Ability to work within a GMP environment and properly gown according to room classifications and procedures

BMSCART

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.