Quality Assurance and Validation Specialist
1 week 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.
As a leading advocate for patient-centric healthcare, Civica Rx aims to ensure that essential medications are accessible and affordable for everyone. Our team of experienced health care and pharmaceutical industry leaders works tirelessly to achieve this goal.
We are currently seeking a highly skilled Validation Engineer II to join our team. This critical role will play a key part in ensuring the quality and safety of our products by leading the commissioning, qualification, and validation (CQV) activities across various equipment, facilities, utilities, products, and processes.
About the Role- This position will be responsible for overseeing all phases of CQV activities, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
- The ideal candidate will have a strong background in engineering or relevant sciences, with at least 8 years of experience in CQV activities.
- Prior experience with sterile injectables, combo-devices, or biologics is highly desirable.
The successful candidate will possess excellent problem-solving skills, analytical thinking, and technical expertise. Strong communication and interpersonal skills are also essential for success in this role, as they will be working closely with cross-functional teams and external stakeholders.
Key Responsibilities- Develop and execute commissioning, qualification, and validation protocols for various equipment and systems.
- 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.
- Serve as Principal Investigator for validation-related excursions.
- Contribute to the continuous improvement of validation processes and procedures.
Salary Range: $90,000 - $110,000 per year, depending on qualifications and experience. Benefits include comprehensive health insurance, retirement plan, and generous paid time off.
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Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx is a mission-driven organization established to reduce chronic generic drug shortages and related high prices in the United States. With over 55 health systems on board, representing over 1,500 hospitals and 30% of U.S. hospital beds, we've made significant strides in addressing this critical issue.In our relentless pursuit of...
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