GxP Facilities Specialist
CRISPR Therapeutics
18 days ago
On-site
Framingham, MA
Operations
Position Summary
- Responsible for day-to-day building and utility operations and repair/maintenance program execution, technician training, and emergency response (including GxP manufacturing environment shutdown support).
Responsibilities
- Perform preventive and corrective maintenance for process equipment and systems; support remediation for follow-up and emergency work.
- Follow all prescribed safety procedures.
- Troubleshoot equipment and systems; repair malfunctions; coordinate work with equipment owners/engineers and external vendors.
- Conduct periodic equipment inspections to ensure proper and safe operation.
- Assist with installation of new equipment; write safety and maintenance procedures.
- Train equipment technicians.
- Lead root-cause troubleshooting and implement immediate corrective actions.
- Use maintenance scheduling software to initiate, execute, and reconcile work orders.
- Respond to alarms and document activities per cGMP; develop alarm remediation with equipment owners.
- Use Quality Management Software; CAPA exception initiation experience preferred.
- Take a leadership role and communicate with management as needed.
- Provide rotating on-call support for 24/7 facility operation and off-hours emergency coverage.
Minimum Qualifications
- 10+ years process support equipment and plant utility maintenance, troubleshooting, and repair.
- 10+ years in a cGMP environment.
- Lead/influence and course-correct as needed.
- Experience installing new equipment/systems and developing maintenance SOPs.
- Interface with multiple external vendors; collaborate with internal/external stakeholders.
- Strong GMP utility/equipment maintenance and controls/automation knowledge.
- CMMS and BMS proficiency (Blue Mountain and/or Alberio a plus).
- Self-driven, data-driven problem solving.
Preferred Qualifications
- Certificate/Associate’s degree; industrial wastewater license; HVAC/R certification; trades license.
- Responsible for day-to-day building and utility operations and repair/maintenance program execution, technician training, and emergency response (including GxP manufacturing environment shutdown support).
Responsibilities
- Perform preventive and corrective maintenance for process equipment and systems; support remediation for follow-up and emergency work.
- Follow all prescribed safety procedures.
- Troubleshoot equipment and systems; repair malfunctions; coordinate work with equipment owners/engineers and external vendors.
- Conduct periodic equipment inspections to ensure proper and safe operation.
- Assist with installation of new equipment; write safety and maintenance procedures.
- Train equipment technicians.
- Lead root-cause troubleshooting and implement immediate corrective actions.
- Use maintenance scheduling software to initiate, execute, and reconcile work orders.
- Respond to alarms and document activities per cGMP; develop alarm remediation with equipment owners.
- Use Quality Management Software; CAPA exception initiation experience preferred.
- Take a leadership role and communicate with management as needed.
- Provide rotating on-call support for 24/7 facility operation and off-hours emergency coverage.
Minimum Qualifications
- 10+ years process support equipment and plant utility maintenance, troubleshooting, and repair.
- 10+ years in a cGMP environment.
- Lead/influence and course-correct as needed.
- Experience installing new equipment/systems and developing maintenance SOPs.
- Interface with multiple external vendors; collaborate with internal/external stakeholders.
- Strong GMP utility/equipment maintenance and controls/automation knowledge.
- CMMS and BMS proficiency (Blue Mountain and/or Alberio a plus).
- Self-driven, data-driven problem solving.
Preferred Qualifications
- Certificate/Associate’s degree; industrial wastewater license; HVAC/R certification; trades license.