Engineering Specialist Operations
2 weeks ago
Civica 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 Engineering Specialist, Operations will play a critical role in the facility start-up at our Civica Petersburg, VA site. This position will support daily engineering operations and the timely production of pharmaceuticals. The ideal candidate will have a consistent track record of achieving results in a fast-paced manufacturing environment.
Key Responsibilities- Collaborate with cross-functional teams to meet production needs and ensure compliance with GMP regulations.
- Support onboarding and technical training of Engineering personnel on Facilities, Utilities, Manufacturing, and Packaging equipment.
- Initiate and complete engineering-related investigations, including data gathering, reports, root cause analysis, and product impact assessment.
- Assist in the creation, revision, and management of engineering documents, such as technical reports and SOPs.
- Provide technical expertise and support to engineering teams, managing Change Controls and CAPAs.
- Support regulatory inspections and ensure compliance with industry best practices.
- Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions.
- Associate's degree in Pharmaceutical Sciences, Engineering, or a related field preferred.
- A minimum of four years' experience in Sterile Injectables, Biopharmaceutical, or Pharmaceutical manufacturing in a GMP environment.
- Experience with sterile fill finish manufacturing and knowledge of clean utilities, plant utilities, metrology, high-speed pen assembly, high-speed aseptic filling, autoclaves, and isolators.
- Detailed-oriented with a focus on accuracy in creating and updating engineering documents.
- Experience in using ERP systems and knowledge of GMP, regulatory requirements, and industry best practices.
- Strong communication and collaboration skills, with a commitment to meeting high-quality standards.
- Knowledge of process improvement environments, including change management, optimizing process flow, and participating in Lean/Six Sigma project teams.
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Engineering Specialist Operations
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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 Engineering Specialist, Operations will play a critical role in the facility...
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Engineering Specialist Operations
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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 team of experienced health care and pharmaceutical industry leaders is committed to doing what is in the best interest of patients.We have expanded our mission beyond the hospital setting...
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Engineering Specialist Operations
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Quality Assurance Engineer
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