Job Description

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 main purpose of the Manager of Safety and Compliance is to implement and manage a program to maintain a qualified and regulatory compliant operation strategy for the New Jersey GMP Facilities Department. The incumbent will be responsible for establishing a program across the New Jersey sites under the operation of the GMP Facilities Department. Main responsibility will be to oversee all CAPA, Deviations, Change Controls and Audit driven actions that are assigned to the GMP Facilities department. The role will also oversee the tier 1 reports and assist in identifying solutions to identified actions with respect to compliance, safety but is not limited to. The incumbent in this role will have specific job tasks and processes to follow to perform their job.

The Manager of Safety and Compliance supports the successful operation of facility, laboratory and business functions at multi-use GMP sites within New Jersey through interaction with internal customers and external service providers. The role is expected to be able to identify issues or unmet needs and initiates projects or programs to address them.

DUTIES AND RESPONSIBILITIES:

* Provides technical knowledge for local regulation, OSHA, FDA regulation and EudraLex with respect to room design, building automation, GMP utilities and safety procedures.
* Prepares asset files including equipment data sheets, impact assessments, P&ID & drawings, factory O&Ms, factory maintenance recommendations, maintenance work plans and procedures.
* Assist in the development and management of a facility document management program to track facility drawings, and project turnover packages.
* Manage logbook strategies for facility equipment owned and maintained by GMP Facilities.
* Assist in establishes effective preventative and predictive maintenance plans for GMP Pharmaceutical facility & process utility equipment according to OEM recommendations, industry standards and process application
* Generates SOPs and Work Practices within Document Management System to establish the Use, Maintenance and Calibration plans for GMP equipment.
* Initiates deviations for maintenance work orders that are out of compliance
* Manages any CAPAs associated with the CMMS, including PMs or Calibrations performed late or out of conformance
* Conducts Historical Performance Reviews on GMP Direct Impact assets and Critical instrumentation maintained and calibrated by the GMP Facilities Department
* Support and track deviations, investigations and CAPA plans for the GMP Facilities Department. Role will include conducting detailed investigations to determine root cause and necessary CAPAs by working cross functionally with Facility Management, QA, Validation and Business Area Management.
* Implement predictive maintenance tools to identify equipment trending to failure to implement repairs prior to failure.
* Support facility operations by providing operational SOPs to manage GMP facility and equipment operations. Procedures may include a USP Water System Operational Procedure or Facility Cleaning.
* Promotes and maintains compliance with corporate, safety, security and regulatory policies.
* Maintains all assigned Corporate, Facilities, GMP and EHS training as required
* Oversee the LOTO and Confined Space procedures for GMP Facility owned and maintained equipment.

REQUIRED COMPETENCIES:

Education and Experience:

* BS degree in mechanical, electrical engineering or similar engineering field or equivalent in work experience
* Minimum 8 years of facilities maintenance/operations experience at an industrial or commercial site or related experience and/or equivalent combination of education and experience
* Minimum 10 years of GMP facility experience
* 3 to 5 years project management experience, not required but beneficial

Knowledge, Skills, and Abilities:

* Strong understanding of building systems including life-safety, lighting, mechanical, electrical, and plumbing
* Strong knowledge of critical utility systems such as compressed gas, vacuum, waste, as well as security and key managements systems and policies
* Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
* Adept in Microsoft Office Suite Word, Project, PowerPoint, Excel and Outlook, Visio and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.
* Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task
* Knowledge of FDA regulations, IBC/IFC building codes, OSHA, NFP, FM, LPDS and UL

WORKING CONDITIONS (US Only):

Physical / Mental Demands:

* Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 50lbs
* Ability to sit, stand, walk and move within workspace for extended periods
* Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling
* Ability to climb ladders and work in elevated areas.

Environmental Conditions:

* Primarily office environment
* 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.

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.