BioSpace
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Validation Engineer II (377)
role at
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 with 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 Veterans 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. Future plans include a 140,000 square‑foot state‑of‑the‑art manufacturing facility in Virginia that will produce a steady supply of more than three dozen sterile injectables and affordable biosimilar insulins.
Position Summary The Validation Engineer II will lead commissioning, qualification, and validation (CQV) activities for new and modified equipment, facilities, utilities, products, and processes. Working closely with system owners and stakeholders—including Operations, Engineering, Laboratories, IT, and Quality Assurance—this role guides CQV activities to a compliant state throughout the lifecycle, authoring and reviewing documents such as procedures, protocols, and change control records. The Validation Engineer II serves as a subject‑matter expert for all CQV activities.
Essential Duties And Responsibilities
Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.
Responsible for all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
Execute validation activity in a timely manner, proactively pursuing details to ensure project completion without avoidable delays.
Evaluate System Change Controls for Validation Impact and support Change Qualification through the creation of relevant Change Actions.
Support the development of Standard Operating Procedures for new processes and equipment.
Manage interpersonal interactions and achieve results across a range of functions within the site, including external communication with system vendors.
Serve as Principal Investigator for validation‑related excursions.
Contribute to the continuous improvement of validation processes and procedures.
Basic Qualifications And Capabilities
Bachelor’s degree in engineering or relevant sciences and 8+ years of CQV experience.
8 years’ experience with sterile injectables, combo‑devices, or biologics.
Advanced degrees or certifications relevant to the role is 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.
Strategic and tactical thinking with attention to detail.
Strong collaborative and influencing skills, able 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
Location Richmond, VA
#J-18808-Ljbffr
Validation Engineer II (377)
role at
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 with 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 Veterans 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. Future plans include a 140,000 square‑foot state‑of‑the‑art manufacturing facility in Virginia that will produce a steady supply of more than three dozen sterile injectables and affordable biosimilar insulins.
Position Summary The Validation Engineer II will lead commissioning, qualification, and validation (CQV) activities for new and modified equipment, facilities, utilities, products, and processes. Working closely with system owners and stakeholders—including Operations, Engineering, Laboratories, IT, and Quality Assurance—this role guides CQV activities to a compliant state throughout the lifecycle, authoring and reviewing documents such as procedures, protocols, and change control records. The Validation Engineer II serves as a subject‑matter expert for all CQV activities.
Essential Duties And Responsibilities
Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.
Responsible for all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
Execute validation activity in a timely manner, proactively pursuing details to ensure project completion without avoidable delays.
Evaluate System Change Controls for Validation Impact and support Change Qualification through the creation of relevant Change Actions.
Support the development of Standard Operating Procedures for new processes and equipment.
Manage interpersonal interactions and achieve results across a range of functions within the site, including external communication with system vendors.
Serve as Principal Investigator for validation‑related excursions.
Contribute to the continuous improvement of validation processes and procedures.
Basic Qualifications And Capabilities
Bachelor’s degree in engineering or relevant sciences and 8+ years of CQV experience.
8 years’ experience with sterile injectables, combo‑devices, or biologics.
Advanced degrees or certifications relevant to the role is 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.
Strategic and tactical thinking with attention to detail.
Strong collaborative and influencing skills, able 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
Location Richmond, VA
#J-18808-Ljbffr