Physical Demands & Work Conditions
- Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
- Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
- Must be comfortable regularly participating in video-based meetings.
Job duties and responsibilities include:
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Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures
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Track and report on equipment downtime, failure trends and develop corrective actions to prevent recurrence
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Planning, scheduling and coordinating onsite and offsite preventative and corrective maintenance, calibration and certification activities to be completed by service providers
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Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS
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Ensure that facilities, utilities, production and laboratory assets are maintained, calibrated, and certified to applicable GMP standards
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Collaboration with peers in the continuous improvement of equipment standards, practices, specifications, procedures, qualifications and business processes
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Lead and/or participate in the identification and development of solutions to stabilize and optimize equipment systems
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Execution of facility preventative and corrective maintenance tasks, small projects and continuous improvements
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Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status, labelling, and assigning required maintenance, calibration and certification plans
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Other duties as assigned
Education & Experience Requirements:
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Bachelor’s degree in Engineering, Life Sciences, Facility Management or equivalent technical experience
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4 years of experience in GMP manufacturing facility, including equipment operation and troubleshooting, and facilities and asset maintenance execution in a GMP manufacturing facility
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Experience in analyzing, managing, and reporting reliability metrics, and managing assets and maintenance activities using a CMMS system
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Experience coordinating onsite and offsite maintenance, calibration and certification activities completed by service providers
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Experience in managing and executing facility and utility projects including repairs, improvements and new installations.
Personal Qualities & Physical Demands:
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Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
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Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
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Willing to support sites after-hours on an as needed or on-call basis
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Strong interpersonal skills and ability to communicate effectively
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Strong problem-solving and critical thinking skills to support making decisions in a timely manner, and desire to improve upon established processes
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Ability to gown and work in clean room areas
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Ability to work in a collaborative manner, independently and as part of a team
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Ability to work in a fast-paced start-up environment while following documented procedures and instructions.
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Ability to work for extended periods of time at a computer
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Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking