- Respond to Customer requests in a professional and timely manner.
- Respond in accordance to cGMP policies and procedures.
- Assist in troubleshooting and emergency situations.
- Complete necessary paperwork, i.e., Logbooks, Work Orders, Maintenance Documentation in accordance with cGMP good documentation practices.
- Participate in various compliance activities including: continuous improvement, deviations, root cause analysis, corrective actions. Train colleagues as necessary.
- Perform all work in accordance with established safety procedures.
- Work with internal and external Automation Technicians. Provide cGMP oversight of external vendors to ensure they are operating within the cGMP policies and site procedures.
- Other duties as assigned.
- Familiarity with FDA / cGxP environments and associated compliance regulations.
- Lead for environmental disruptions to classified areas.
- Ensures that room pressure alarm coding complies with BMS global standards.
- Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements.
- Maintain current status of specifications and procedures of systems related to building automation.
- Ensures timely response to disruptions
- Knowledge of typical CAR-T Cell Therapy upstream and downstream processing and support equipment.
- Interface with operators and provides technical expertise as Subject Matter Expert for assigned equipment ensuring continued compliance to regulatory, company and site policy and procedure.
- Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
- Sponsor and support the change initiatives and the implementation of process improvement initiatives.
- Initiate, own, and follow up change controls.
- Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
- Maintenance of Building Automation and HVAC systems.
- Must be competent in the use of CMMS to schedule track and approve maintenance work.
- Must be capable of reading and interpreting P&ID diagrams, electrical drawings, and technical automation documentation.
- Must be familiar with the use of root cause analysis, five whys and basic six sigma troubleshooting techniques to support investigations and corrective actions.
- Provide daily oversight of Building Automation Technicians.
- Coordinate routine maintenance and project work with Business Area Owners and Facility Planners.
- Review maintenance work orders within the CMMS.
- Review and approve documents related to additions and modifications to the Building Automation System.
- Provides oversight of GMP training curriculum for Automation technicians and external service providers.
- 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 automation/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.
- In depth understanding of classified area's pressurization schemes to maintain clean room environment based on ISO 14644 Standards.
- Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in engineering (mechanical preferred).
- Be proficient in cGMP guidelines in accordance with company policy and procedures. Provide direct oversite of automation technicians and external vendors to ensure compliance.
- Complete and review documentation associated with automation and maintenance work in order to ensure compliance with GMP, GDP and change control procedures.
- Capability to work with short deadlines and simultaneous activities.
- Knowledge of instrumentation, controls and HVAC equipment used in Building Automation Applications.
- Expert written and verbal communication skills.
- Proficiency in Microsoft Teams, Microsoft Word, Excel and Outlook.
- Experience using Computerized Maintenance Management Systems (CMMS). Experience using BMRAM CMMS is desired.
- Use of root cause analysis (RCA) to resolve technical issues.
- Minimum Bachelor of Science in engineering Minimum of 3 years in Pharmaceutical Industry.
- Minimum of 3 years work with Building Automation and/or HVAC systems is preferred
- Work required in and around laboratory and regulated environments.
- Ability to lift greater than 50 lbs.
- Ability to perform on elevated work platforms.
- Ability to work extended hours, or a modified work schedule as required for coverage of startup activities for future projects and support of ongoing 24/7 operations.
- Ability to sit, stand and move within workspace for extended periods.
- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
- 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.
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Automation and Compliance Engineer - New Jersey, United States - Bristol Myers Squibb
Description
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Building Automation and Compliance Engineer is responsible for maintaining the compliance of Building Automation Systems installed at the Summit West manufacturing site. The Building Automation and Compliance Engineer will provide direct supervision to Building Automation technicians operating at the Summit West site. This includes execution, review, and approval of maintenance work orders using the computerized manufacturing and maintenance system (CMMS). The Building Automation and Compliance Engineer ensures that Building Automation Systems and Environmental monitoring systems are functioning properly and remain in compliance. This position will lead investigations related to the Building Automation System, the Environmental monitoring system, HVAC and building controls.
Shifts Available:
TBD
Responsibilities:
General Role:
Working under minimal direction and guidance and be self-motivated, responsibilities shall include but not be limited to the following:
The candidate must have experience in the following areas:
PHYSICAL /MENTAL DEMANDS:
#LI-ONSITE
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through scienceTM , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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