Civica Rx
Principal Engineer: Utilities and HVAC (920)
Civica Rx, Virginia State University, Virginia, us, 23806
Principal Engineer: Utilities and HVAC (920)
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Principal Engineer: Utilities and HVAC (920)
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Civica Rx . About Civica Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare, with over 300 medications currently in shortage according to industry and FDA reports. Civica, a market-based nonprofit founded in 2018, aims to prevent and mitigate drug shortages, serving nearly 60 health systems and supplying various government agencies. The organization is expanding its manufacturing capabilities and initiatives to ensure affordable and reliable access to essential medicines. Job Purpose The Principal Engineer: Utilities & HVAC is the site SME for GMP HVAC and Critical Utility systems, responsible for their operation, compliance, and continuous improvement at our new Petersburg, VA facility. The role involves overseeing system reliability, safety, and efficiency during construction, startup, and ongoing operations. Key Responsibilities Serve as SME with deep technical expertise in GMP HVAC, Utilities, and ancillary systems, understanding their application in pharmaceutical manufacturing. Ensure processes comply with regulatory standards and company policies. Support risk assessments and participate in project teams and committees. Lead or support system design, verification, and qualification activities. Develop documentation to demonstrate system qualification and control. Monitor utility systems, maintain KPIs, and ensure proper operation. Create operational and maintenance instructions for equipment and systems. Implement maintenance and reliability best practices. Lead troubleshooting and root cause analysis for equipment failures. Coordinate communication and notifications regarding utility issues. Support inspections, investigations, and internal audits. Maintain effective communication with site teams and utilize systems like DMS and CAPA. Develop and deliver operations training for utility systems. Use statistical tools for process control and investigations. Participate in safety reviews and hazard analysis meetings. Qualifications Bachelor’s degree in engineering or relevant sciences with 6+ years of GMP Utilities experience. 5+ years in sterile injectables, biologics, or related fields; start-up experience preferred. Additional certifications or advanced degrees are a plus. Strategic, detail-oriented thinking with strong collaboration skills. Ability to work effectively in fast-paced, cross-functional teams. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and IT Industry: Pharmaceutical Manufacturing
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Join to apply for the
Principal Engineer: Utilities and HVAC (920)
role at
Civica Rx . About Civica Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare, with over 300 medications currently in shortage according to industry and FDA reports. Civica, a market-based nonprofit founded in 2018, aims to prevent and mitigate drug shortages, serving nearly 60 health systems and supplying various government agencies. The organization is expanding its manufacturing capabilities and initiatives to ensure affordable and reliable access to essential medicines. Job Purpose The Principal Engineer: Utilities & HVAC is the site SME for GMP HVAC and Critical Utility systems, responsible for their operation, compliance, and continuous improvement at our new Petersburg, VA facility. The role involves overseeing system reliability, safety, and efficiency during construction, startup, and ongoing operations. Key Responsibilities Serve as SME with deep technical expertise in GMP HVAC, Utilities, and ancillary systems, understanding their application in pharmaceutical manufacturing. Ensure processes comply with regulatory standards and company policies. Support risk assessments and participate in project teams and committees. Lead or support system design, verification, and qualification activities. Develop documentation to demonstrate system qualification and control. Monitor utility systems, maintain KPIs, and ensure proper operation. Create operational and maintenance instructions for equipment and systems. Implement maintenance and reliability best practices. Lead troubleshooting and root cause analysis for equipment failures. Coordinate communication and notifications regarding utility issues. Support inspections, investigations, and internal audits. Maintain effective communication with site teams and utilize systems like DMS and CAPA. Develop and deliver operations training for utility systems. Use statistical tools for process control and investigations. Participate in safety reviews and hazard analysis meetings. Qualifications Bachelor’s degree in engineering or relevant sciences with 6+ years of GMP Utilities experience. 5+ years in sterile injectables, biologics, or related fields; start-up experience preferred. Additional certifications or advanced degrees are a plus. Strategic, detail-oriented thinking with strong collaboration skills. Ability to work effectively in fast-paced, cross-functional teams. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and IT Industry: Pharmaceutical Manufacturing
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