Specialist, Commissioning Engineer I

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The Commissioning Engineer I will be part of the Commissioning team reporting to Sr. Manager, Commissioning Engineering and support clinical and commercial Devens manufacturing facility. This position may lead contractors for complete asset life cycle onboarding oversight of commissioning and any other effort arising from design and implementation of new/modified asset(s) as part of capital projects at the Devens site. The incumbent will apply existing and new knowledge of Engineering Project Management to support multiple, high-pace projects across multiple functions as part of the commissioning phase of asset introduction and/or modifications. This position will lead, execute and assist in commissioning activities for capital projects and collaboratively develop our commissioning protocols and practices. This position is responsible for facilities, utilities, equipment and analytical instruments commissioning project activities in both GxP and non-GxP systems. This position will interface with key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control, Qualification, Manufacturing Engineering, Facilities operations/maintenance, Validation and Manufacturing.

Key Responsibilities:
Executes and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP
processes, qualification of environmental chambers and qualification of critical and non-critical process utility systems.
Provides Single Point of Contact (SPOC) on all commissioning activities for a specific manufacturing area (Production
Support, Cell Culture, Purification, and Critical Utilities), working with designated peers to create a team/triage
environment.
Assignment of SPOC to designated manufacturing area is based on demonstrated technical knowledge and experience
with associated equipment/systems.
Lead and execute vendor qualification protocols and triage commissioning deviation as part of impact to the
commissioning activities.
Performs commissioning testing, vendor installation, vendor operational qualification (I/OQ) of systems arising from
projects.
Draft / oversight of commissioning protocol, execute and write commissioning reports for GxP (direct impact system)
and non-GxP (not direct impact system).
Work with vendors and project engineering to ensure systems are ready for installation, and start-up testing. Work with
support department such as Digital Plant, Facilities, Metrology and Maintenance to ensure systems are installed
adequately and ready for qualification (for GxP direct impact system) or released to system owners for system use (for
non-GxP systems).
Support multiple projects while serving as a point of contact for capital execution projects. Partner with project
managers to determine project priorities, track progress toward project milestones and deliverables, and provide regular project status updates to site management.
Works collaboratively with Engineering, Digital Plant, Manufacturing and Quality.
Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and
increase efficiencies.
Ensure alignment with BMS directives and industry guidelines on commissioning.
Performs other duties as assigned.

Knowledge & Skill:
You should have the ability to execute smaller, but complex technical projects. You must have demonstrated
effectiveness working in both a team environment as well as an individual contributor role.
Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred.
A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.
Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures

Qualifications:
A minimum of 1+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.
Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required.

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 science™ ", 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.

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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.

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