Cleaning Validation Engineer II

Civica Rx

  • Petersburg, VA
  • Permanent
  • Full-time
  • 2 months ago
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 atJob Description:The Cleaning Validation Engineer II will be responsible for leading the cleaning validation program to support new and modified equipment, products, and processes, in support of project, operational, and quality objectives. Working closely with system owners and related stakeholders (Operations, Engineering, Laboratories, and Quality Assurance). This role will guide and oversee the cleaning validation activities to ensure they are in a compliant state throughout their lifecycle. This includes authoring, reviewing, and executing equipment and cleaning validation documentation as well as related documents for the role (e.g., procedures and change control records). Serves as a subject matter expert for cleaning validation activities.The Petersburg, VA site serves as Civica’s new fill-finish facility, dedicated to manufacturing and supplying essential generic sterile injectable medications.Essential Duties and Responsibilities:
  • Lead the development and execution of cleaning validation design, qualification, and validation protocols for various equipment and systems.
  • Responsible for all phases (stages 1, 2 and 3) of the cleaning validation activity, including requirements gathering, validation planning, protocol generation, test execution, design documentation, and system release.
  • Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
  • Evaluate System Change Controls for Validation Impact. Support Change Qualification through the creation of relevant Change Actions.
  • Support the development of Standard Operating Procedures for new processes and equipment.
  • Interpersonal skills to manage interactions and achieve results across a range of functions within the site. It may also extend to external communication with system vendors.
  • Serve as Principal Investigator for cleaning validation-related excursions.
  • Contribute to the continuous improvement of validation processes and procedures
  • Support other areas of validation, as needed, including equipment, sterilization, utilities, and facilities.
Basic Qualifications and Capabilities:
  • Bachelor’s degree in engineering or relevant sciences and 6+ years of validation experience, with specialization in cleaning validation.
  • Knowledge and experience with all phases/stages (1, 2 and 3) of cleaning validation, that includes maximum carryover calculations for limits assessment, understanding and application of Health based exposure Limits (HBEL), ADE/PDE, NOEL, VRL, cycle development, rinse and swab method analytical and recovery studies, sample collection, worst case assessment for equipment and products, spray ball coverage testing, continued cleaning process verification after equipment release.
  • Experience with cleaning validation of Formulation/Filling vessels, Filling equipment (example: manifolds/needles etc), CIP skids and Parts Washer.
  • 6+ years’ experience with sterile injectables, combo-devices, or biologics.
  • Experience with personnel training for visual inspection and swab qualification.
  • Advanced degrees or certifications relevant to the role is a plus.
  • Knowledge of regulatory requirements (cGMP, FDA, WHO, etc.).
  • Experience authoring, approving, and executing cleaning validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
  • Self-directed with problem-solving, analytical, and technical skills.
  • Ability to think strategically and tactically (detail-oriented).
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
  • Experience in a process improvement environment, including change management and participating in Lean/Six Sigma project teams.
PREFERRED QUALIFICATIONS
  • Experience with single-use components in drug product formulation, process validation, sterile filtration, and aseptic filling applications.
  • Start-up experience preferred.
Physical Demands and Work Environment:The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use hands or fingers and handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually low to moderate.The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.

Civica Rx