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 experie