Civica Rx
About Civica:
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare, reaching an all-time high with over 300 medications reported in shortage, according to industry and FDA reports.
Shortages pose risks to patients and waste hospital resources.
Civica is a market-based nonprofit established in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Currently, nearly 60 health systems, representing over 1,400 hospitals and about one-third of U.S. hospital beds, are members. Civica supplies medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile, serving 49 states.
The organization’s mission extends beyond hospitals to consumers via CivicaScript, making affordable outpatient generic medicines available. Civica partners with manufacturers, payors, pharmacy benefit managers, and pharmacies to develop quality generics and pass savings to consumers.
Civica’s new 140,000 sq. ft. manufacturing facility in Virginia will produce sterile injectables, including drugs in shortage and affordable biosimilar insulins, ensuring access regardless of insurance status.
The Civica Foundation, a 501(c)(3), supports philanthropic efforts to produce and distribute affordable medications, notably insulin for all Americans, in partnership with diabetes ecosystem leaders.
Civica advocates for patients over profits, emphasizing the importance of eliminating shortages and high prices for patient well-being.
Learn more at
www.civicarx.org
. Job Description
Civica seeks a Process Engineer with expertise in pharmaceutical manufacturing, especially sterile injectable formulation and filling, barrier systems, and single-use fluid components. The Petersburg facility, nearing completion, will be the first US generic drug plant using all isolator-style high-speed filling lines. During construction, you will manage OEMs and engineering providers through commissioning, qualification, and validation, and lead process development for high-speed filling lines and Civica’s insulin line ( civicainsulin.org ). During operations, you will be the System Owner/SME for the Terminal Sterilization system, supporting process optimization, equipment uptime, and product transfers from contract manufacturing to fulfill Civica’s patient-centered mission. Essential Duties and Responsibilities
Support commissioning, qualification, and validation of sterilization, compounding, and filling systems, including SAT, IQ/OQ, PQ, and aseptic process simulation. Manage equipment vendors, oversee maintenance, calibration, training, continuous improvement, and spare parts assessment. Develop sterilization cycles, GMP documentation, and electronic batch records for filling processes. Assist in transitioning to manufacturing and ramp-up by improving equipment reliability via continuous improvement and TPM. Coordinate with Aseptic Operations to support process launches. Lead and participate in cross-functional investigations, process improvements, using DMAIC and FMEA tools. Manage changes in sterilization and filling systems per change control procedures. Participate in regulatory inspections as SME. Basic Qualifications
Experience with parenteral processing equipment, formulation, filling, inspection, and packaging. Support for aseptic filling equipment and barrier systems (isolator or RABS). Ability to resolve technical issues and lead projects. Excellent communication skills in English. Strong mechanical aptitude. Qualifications
Bachelor’s in engineering, Materials Science, Biology, or related field. 3-5 years in a cGMP environment (pharmaceutical, medical device, or food manufacturing). Ability to manage diverse teams and execute on-floor activities like FAT, SAT, IQ/OQ, and engineering batches. Flexibility to adapt to changing priorities. Skill in explaining complex technical issues to external stakeholders. Preferred Qualifications
SME knowledge of high-speed aseptic filling and barrier systems. Expertise in single-use components for drug formulation and aseptic filling. Experience managing large capital projects ($1MM+). Experience with greenfield CQV and startup preferred. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations.
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www.civicarx.org
. Job Description
Civica seeks a Process Engineer with expertise in pharmaceutical manufacturing, especially sterile injectable formulation and filling, barrier systems, and single-use fluid components. The Petersburg facility, nearing completion, will be the first US generic drug plant using all isolator-style high-speed filling lines. During construction, you will manage OEMs and engineering providers through commissioning, qualification, and validation, and lead process development for high-speed filling lines and Civica’s insulin line ( civicainsulin.org ). During operations, you will be the System Owner/SME for the Terminal Sterilization system, supporting process optimization, equipment uptime, and product transfers from contract manufacturing to fulfill Civica’s patient-centered mission. Essential Duties and Responsibilities
Support commissioning, qualification, and validation of sterilization, compounding, and filling systems, including SAT, IQ/OQ, PQ, and aseptic process simulation. Manage equipment vendors, oversee maintenance, calibration, training, continuous improvement, and spare parts assessment. Develop sterilization cycles, GMP documentation, and electronic batch records for filling processes. Assist in transitioning to manufacturing and ramp-up by improving equipment reliability via continuous improvement and TPM. Coordinate with Aseptic Operations to support process launches. Lead and participate in cross-functional investigations, process improvements, using DMAIC and FMEA tools. Manage changes in sterilization and filling systems per change control procedures. Participate in regulatory inspections as SME. Basic Qualifications
Experience with parenteral processing equipment, formulation, filling, inspection, and packaging. Support for aseptic filling equipment and barrier systems (isolator or RABS). Ability to resolve technical issues and lead projects. Excellent communication skills in English. Strong mechanical aptitude. Qualifications
Bachelor’s in engineering, Materials Science, Biology, or related field. 3-5 years in a cGMP environment (pharmaceutical, medical device, or food manufacturing). Ability to manage diverse teams and execute on-floor activities like FAT, SAT, IQ/OQ, and engineering batches. Flexibility to adapt to changing priorities. Skill in explaining complex technical issues to external stakeholders. Preferred Qualifications
SME knowledge of high-speed aseptic filling and barrier systems. Expertise in single-use components for drug formulation and aseptic filling. Experience managing large capital projects ($1MM+). Experience with greenfield CQV and startup preferred. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations.
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