Quick overview
Job description
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 Key Responsibilities
- Perform or coordinate preventive and corrective maintenance on the facility and associated infrastructure
- Coordinate onsite preventative and corrective maintenance to be completed by service providers
- Escort of service providers in restricted access areas during execution of facility and asset maintenance activities
- Review and approval of service provider documentation, and completion of tasks in the CMMS
- Maintain documentation in accordance with company standards
- Ensure that facilities and associated infrastructure are maintained to applicable regulatory and GMP requirements
- Participate in the continuous improvement of facility standards, specifications, procedures, and business processes
- Other duties as assigned
- Respond to emergency maintenance requests during off-hours as needed
Education & Experience Requirements
- High school diploma or GED required, associate’s degree or certification in facility maintenance preferred
- 2 years of experience in GMP manufacturing facility, preferably cell therapy, biotechnology or pharmaceutical
- Experience in use of a CMMS system for managing execution of maintenance activities
- Experience in execution of preventative and corrective maintenance of a GMP manufacturing facility and associated infrastructure
- Experience coordinating onsite maintenance activities completed by service providers
Personal Qualities & Physical Demands
- Ability to multitask and manage multiple responsibilities simultaneously; able to prioritize
- Demonstrates strong work ethic and problem-solving skills
- Willing to support sites after-hours on an as needed or on-call basis
- Strong people skills and ability to communicate effectively
- Ability to gown and work in cleanroom areas
- Ability to work in a collaborative manner, independently and as part of a team
- Ability to work in a fast-paced start-up environment while following documented procedures and instructions.
- Ascend/descend stairs within the workspace; job requires sitting, standing, walking
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