Commissioning Engineering Manager

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The position, Manager, Commissioning Engineering will be part of the Site Validation team reporting to Head of Validation that support clinical and commercial Devens Facility manufacturing. This position will lead a team of full-time engineers and 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 is the technical program lead for Commissioning which provides support to Capital Project Delivery by developing and implementing commissioning strategies, oversee and manage the commissioning of capital projects and collaboratively develop our commissioning policies and practices. This position is responsible for facilities, utilities, equipment and analytical instruments commissioning project activities in both GxP and non-GxP systems.

Acting in the capacity of commissioning technical program lead and ensures commissioning resources available for capital project teams, 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.

The position is accountable for organizing and completion of commissioning program documents and deliverable templates in accordance with BMS project practices and GMP qualification policies. Other responsibilities of this position include but are not limited to: contractor management, vendor qualification, scheduling of vendor qualification, factory acceptance testing, and assisting in asset onboarding to the site cMMS system and other duties as assigned.

Duties & Responsibilities

• Lead Commissioning functions within the Validation Engineering group responsible for technical program lead for Commissioning which provides support to Capital Project Delivery by developing and implementing commissioning strategies, oversee and manage the commissioning of capital projects and collaboratively develop our commissioning policies and practices. This position will be responsible for facilities, utilities, equipment and analytical instruments commissioning project activities in both GxP and non-GxP systems.

• Leads functions responsible for commissioning, vendor installation, operational and performance qualification (I/O/PQ) of systems arising from projects.

• Draft / oversight of commissioning protocol, execute and write commissioning reports.

• 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).

• Manage 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.

• Develops and leads a high-performance team responsible for commissioning execution, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition.

• Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies.

• Performs other duties as assigned

Knowledge & Skill

• Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required. A Masters/Graduate degree in a technical discipline is preferred.

• 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.

• A minimum of 6+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.

• Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred.

• Previous managerial experience (is preferred) which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources preferred.

• A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.

• Experienced self-motivated individual who can handle multiple priorities to meet project team goals and timelines.

• The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.

• Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.

• Proven ability working in a matrix environment and leading multi-level / cross-functional teams to achieve the highest performance in meeting site and departmental objectives.

#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 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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