Manager, Validation
2 months ago
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 ofhealthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.
Civicarecently announced plans to expand its mission, via a unit called CivicaScript,to into the outpatient pharmacy space and to manufacture and distribute insulin that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life-sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the NewEngland Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Job Description:
The Manager, Validation will support Aseptic Simulation Studies performing for Sterile Products and Bio-similar products at Civica Rx, Petersburg. This role will be responsible for leading Aseptic Simulation studies from early planning, building strategies in a collaborative manner across internal disciplines and external partners and contractors.
Essential Duties and Responsibilities:
- Design and develop the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.
- Conduct risk assessments and mitigate risks associated with aseptic processing operations.
- Consider multiple factors in the design of APS studies including Bracketing / Definition of Simulations / Interventions, clean room Staff qualification, Risk Base determination of Interventions, Microbiological Investigations and Environmental Monitoring as Part of the Media Fill, Incubation, Assessment and Evaluation.
- Manage the APS activities for sterile injectable vials, cartridges, pre fill syringes, and pens.
- Share knowledge and expertise with respect to start up and validation including utilities and equipment.
- Drive enhancement of sterile standards within the manufacturing environment. Resolve complex problems by applying sound sterile operation principles, utilizing knowledge from FDA & European regulatory guideline, PDA and Annex 1 requirement.
- Investigate Deviations and conduct Root Cause Analysis.
- Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
- Support product preapproval inspection. The role has direct interaction with regulatory agencies during site inspections.
- Understand and implement manufacturing control strategy for various unit operation areas.
- Define enabling studies necessary for product submission and conduct those internally and externally with collaboration from different departments.
Basic Qualifications and Capabilities:
- Bachelor's degree in microbiology, engineering, or a related discipline.
- 8+ years in a sterile cGMP production environment.
- Direct experience with APS including knowledge of the requirements of Annex 1 and PDA technical reports.
- Must have extensive hands-on experience in the development of aseptic programs including 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.
Preferred Qualifications:
- A post graduate degree is preferred.
- Experience with cleaning validation strongly preferred.
- Direct interaction experience with regulatory agencies.
-
Validation Manager, Sterile Products
4 weeks ago
Petersburg, United States 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 team of health care and pharmaceutical industry leaders is dedicated to doing what is in the best interest of patients.Job Description:The...
-
Validation Engineer
3 weeks ago
Petersburg, United States PSC Biotech Full timeJob DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a...
-
Associate Director, Validation
3 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...
-
Validation Engineer II
1 month ago
Petersburg, United States Civica Rx Full timeAbout Civica Rx:Civica 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 make essential generic medications affordable and accessible to all Americans.We have a team of experienced health care and...
-
Validation Engineer II
2 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 sterile...
-
Validation Engineer
2 weeks ago
Petersburg, United States PSC Biotech Full timePSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled...
-
Quality Assurance Engineer
2 months 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...
-
Validation Engineer
2 weeks ago
Petersburg, United States PSC Biotech Full timePSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled...
-
Sterile Product Validation Manager
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeJob Description:The Validation Manager for Sterile Injectables will lead Aseptic Simulation Studies for Sterile Products and Bio-similar products at Civica Rx, Petersburg. This role will be responsible for designing and developing the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.Key Responsibilities:Design and develop the...
-
Quality Assurance Engineer II
2 months 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...
-
Quality Assurance Engineer II
2 months 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...
-
Quality Assurance Engineer
2 weeks ago
Petersburg, VA, 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. S....
-
Quality Assurance Engineer II
2 weeks ago
Petersburg, VA, 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 of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. S. hospital beds....
-
Manufacturing Manager
1 month ago
Petersburg, United States Sterling Life Sciences Full timeJob Title: Manager of Manufacturing, Science and TechnologyA unique opportunity exists for an exceptional individual to lead the transfer of sterile biologics production processes and technologies from R&D into site operations.Key Responsibilities:Develop and implement biologics process control strategy documents, technology transfer change controls,...
-
Manager Lab IT
3 weeks ago
Petersburg, United States Global Recruiters of Dublin (GRN Dublin) Full timeEssential Duties and Responsibilities: Identify and drive computerized system innovation and improvement opportunities, leveraging new technologies and methodologies. Drive the selection, installation, testing, maintenance, training, and support of laboratory systems. Manage the budget for IT Laboratory Systems, resources, and vendors, ensuring the optimal...
-
Computerized System Manager
1 month ago
Petersburg, United States 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 patients have access to affordable medications.Job DescriptionThe Computerized System Manager for Laboratory IT...
-
Senior Retail Sales Manager
1 month ago
Petersburg, West Virginia, United States Portables Full timeh3Job Description/h3pAs a Senior Retail Sales Manager at Portables, an AT&T Authorized Retailer, you will be responsible for representing the company in a professional manner. You will teach and create leaders for the future while making decisions to keep the company's interests first. Leaders are expected to create a productive work environment and are...
-
Facilities Management Director
4 weeks ago
Petersburg, United States City of Petersburg, VA Full timeJob SummaryThe City of Petersburg, VA is seeking a highly skilled and experienced Facilities Management Director to oversee the daily operations of the City's Facility Management Division. This is a key leadership role that requires a strong understanding of facilities management principles, practices, and procedures.Key Responsibilities- Develop and...
-
Facilities Management Director
4 weeks ago
Petersburg, United States City of Petersburg, VA Full timeJob SummaryWe are seeking a highly skilled and experienced Facilities Management Director to join our team at the City of Petersburg, VA. The successful candidate will be responsible for managing and directing the daily operation of the City's Facility Management Division, ensuring the viable functionality of all City buildings and the availability of...
-
Manager, Computerized Systems
2 months ago
Petersburg, United States Civica Rx Full timeAboutCivica 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...
