BioSpace
About Civica
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market‑based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one‑third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states. Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like‑minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. Civica’s new 140,000 square foot state‑of‑the‑art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status. The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients. Join us. Learn more at www.civicarx.org.
Position Summary The Validation Engineer II will lead the commissioning, qualification, and validation (CQV) of new and modified equipment, facilities, utilities, products, and processes to support project, operational, and quality objectives. Working closely with system owners and stakeholders, the role guides CQV activities to maintain compliance throughout the lifecycle, authoring, reviewing, and executing related documentation such as protocols, procedures, and change control records. Serves as subject‑matter expert for CQV activities.
Essential Duties and Responsibilities
Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.
Oversee all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
Execute validation activity timely, proactively scheduling to avoid delays.
Evaluate system change controls for validation impact and support change qualification through creation of relevant change actions.
Support development of standard operating procedures for new processes and equipment.
Manage interpersonal interactions and achieve results across functions at the site, including external communication with system vendors.
Serve as principal investigator for validation‑related excursions.
Contribute to continuous improvement of validation processes and procedures.
Basic Qualifications and Capabilities
Bachelor’s degree in engineering or relevant sciences and at least 8 years of CQV experience.
At least 8 years’ experience with sterile injectables, combo‑devices, or biologics.
Advanced degrees or relevant certifications are a plus.
Knowledge of regulatory requirements (cGMP, FDA, etc.).
Experience authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
Self‑directed with strong problem‑solving, analytical, and technical skills.
Detail‑oriented, able to think strategically and tactically.
Strong collaborative and influencing skills to work well in a cross‑functional, matrixed environment.
Ability to lead, take ownership, and follow through on assigned projects.
Demonstrated ability to work in a fast‑paced team environment, meet deadlines, and prioritize work.
Experience in a process improvement environment, including change management and participation in Lean/Six Sigma project teams.
Ability to work autonomously within established guidelines, procedures, and practices.
Preferred Qualifications
Experience in a sterile fill‑finish facility.
Experience with single‑use components in drug product formulation, sterile filtration, and aseptic filling applications.
Start‑up experience preferred.
Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
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Position Summary The Validation Engineer II will lead the commissioning, qualification, and validation (CQV) of new and modified equipment, facilities, utilities, products, and processes to support project, operational, and quality objectives. Working closely with system owners and stakeholders, the role guides CQV activities to maintain compliance throughout the lifecycle, authoring, reviewing, and executing related documentation such as protocols, procedures, and change control records. Serves as subject‑matter expert for CQV activities.
Essential Duties and Responsibilities
Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.
Oversee all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
Execute validation activity timely, proactively scheduling to avoid delays.
Evaluate system change controls for validation impact and support change qualification through creation of relevant change actions.
Support development of standard operating procedures for new processes and equipment.
Manage interpersonal interactions and achieve results across functions at the site, including external communication with system vendors.
Serve as principal investigator for validation‑related excursions.
Contribute to continuous improvement of validation processes and procedures.
Basic Qualifications and Capabilities
Bachelor’s degree in engineering or relevant sciences and at least 8 years of CQV experience.
At least 8 years’ experience with sterile injectables, combo‑devices, or biologics.
Advanced degrees or relevant certifications are a plus.
Knowledge of regulatory requirements (cGMP, FDA, etc.).
Experience authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
Self‑directed with strong problem‑solving, analytical, and technical skills.
Detail‑oriented, able to think strategically and tactically.
Strong collaborative and influencing skills to work well in a cross‑functional, matrixed environment.
Ability to lead, take ownership, and follow through on assigned projects.
Demonstrated ability to work in a fast‑paced team environment, meet deadlines, and prioritize work.
Experience in a process improvement environment, including change management and participation in Lean/Six Sigma project teams.
Ability to work autonomously within established guidelines, procedures, and practices.
Preferred Qualifications
Experience in a sterile fill‑finish facility.
Experience with single‑use components in drug product formulation, sterile filtration, and aseptic filling applications.
Start‑up experience preferred.
Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
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