Sterile Product Validation Manager
1 day ago
Civica Rx is seeking a highly skilled Manager, Validation to support the development and implementation of aseptic simulation studies for sterile products. This role will be responsible for leading cross-functional teams to design, develop, and execute APS programs, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities- Design and develop APS programs for sterile injectable vials, cartridges, pre-fill syringes, and pens.
- Conduct risk assessments and mitigate risks associated with aseptic processing operations.
- Develop and implement strategies for clean room staff qualification, risk-based determination of interventions, microbiological investigations, and environmental monitoring.
- Manage APS activities for sterile injectable products, including utilities and equipment.
- Drive enhancement of sterile standards within the manufacturing environment.
- Investigate deviations and conduct root cause analysis.
- Support product pre-approval inspections and interact with regulatory agencies.
- Develop and implement manufacturing control strategies for various unit operation areas.
- Bachelor's degree in microbiology, engineering, or a related discipline.
- 8+ years of experience in a sterile cGMP production environment.
- Direct experience with APS, including knowledge of Annex 1 and PDA technical reports.
- Extensive hands-on experience in aseptic program development, clean room qualification, and environmental monitoring.
- Experience with biological production processes.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
- Post-graduate degree.
- Experience with cleaning validation.
- Direct interaction experience with regulatory agencies.
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Sterile Products Validation Manager
5 days ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout the RoleCivica Rx is seeking a highly skilled Manager, Validation to join our team in Petersburg, VA. As a key member of our sterile products team, you will be responsible for leading Aseptic Simulation Studies for Sterile Products and Bio-similar products.Key ResponsibilitiesDesign and develop the Aseptic Process Simulation (APS) program for Aseptic...
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Validation Engineer II
1 week ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.We are a collaborative effort between health systems and philanthropies, with a team of...
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Validation Engineer II
4 days ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.Job SummaryThe Validation Engineer II will play a critical role in leading the commissioning,...
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Process Engineer
1 week ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to do what's in the best interest of patients.We are a collaborative effort between health systems and philanthropies, with a team of experienced healthcare and pharmaceutical...
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Process Engineer
1 week ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to do what's in the best interest of patients.Job DescriptionWe are seeking a highly skilled Process Engineer to join our team at our Petersburg, VA facility. As a Process...
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Manufacturing Manager
5 days ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.Job SummaryThe Manager, Manufacturing Nested Filling, will play a critical role in the facility...
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Manager, Validation
2 weeks ago
Petersburg, United States Civica Rx Full timeCivica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team ofhealthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over...
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Manager, Validation
3 months ago
Petersburg, United States Civica Rx Full timeAbout Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly...
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Validation Engineer II
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...
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Validation Engineer II â
1 month ago
Petersburg, United States Civica Rx Full timeAbout Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. âRace to the bottomâ pricing of mostly...
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Quality Assurance Engineer II
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to provide essential generic sterile injectable medications to patients in need.Job SummaryThe Quality Assurance Engineer II will join our team at the Petersburg, Virginia site,...
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Process Engineer
3 days ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to do what's in the best interest of patients.We are a team of experienced healthcare and pharmaceutical industry leaders working together to make a difference. Our goal is to...
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Quality Assurance Engineer
1 week ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.We are led by an experienced team of healthcare...
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Sterile Processing Director
5 days ago
Lynchburg, VA , USA, United States Centra Health Full timeAbout the RoleWe are seeking a highly skilled and experienced Sterile Processing Director to join our team at Centra Health. As a key member of our healthcare team, you will be responsible for overseeing the Sterile Processing operations at our hospitals, ensuring the highest standards of quality, safety, and service.Key ResponsibilitiesFacilitate the...
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Sterile Processing Director
2 weeks ago
Lynchburg, VA , USA, United States Centra Health Full timeAbout the RoleWe are seeking a highly skilled and experienced Sterile Processing Director to join our team at Centra Health. As a key member of our healthcare team, you will be responsible for overseeing the Sterile Processing operations at our hospitals, ensuring the highest level of quality, safety, and service.Key ResponsibilitiesManage the Sterile...
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Process Engineer
6 days ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to do what's in the best interest of patients.Job DescriptionWe are seeking a Process Engineer with expertise in pharmaceutical drug...
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Quality Assurance Engineer II
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They...
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Quality Assurance Engineer II
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They...
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Quality Assurance Engineer
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They...
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Associate Director, Quality Assurance
1 week ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.Job Description:Associate Director, Quality Assurance - EngineeringWe are seeking an experienced...
