Validation Engineer
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, providing contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. We also operate our own cutting edge cancer research laboratories, developing proprietary, radiotherapeutic medicines. The company expects rapid growth in the next few years.
Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
We are looking for a Validation Engineer to support our facility and team full-time and on-site, on a 4/10 hour day shift, Sunday-Wednesday.
Responsibilities:
- Prepare and execute protocols for validation or performing testing of analytical and manufacturing equipment, process, or systems used for radiopharmaceutical manufacturing in a cGMP environment.
- Analyze data from validation tests to determine if systems and processes meet required criteria and specifications according to regulatory requirements and industry standards.
- Collaborates and coordinates with appropriate departments and staff to schedule and implement validation testing.
- Assist with the maintenance and upkeep of validated equipment and systems to ensure continual compliance.
- Maintain database of equipment and systems, including schematics, qualification records, maintenance records, and validation results.
Education and Qualifications:
- Bachelor’s degree in engineering or similar discipline required.
- 2-4 year prior experience with equipment validation in a cGMP facility required.
- CQE (Certified Quality Engineer) preferred.
- Familiarity with Blue Mountain Regulatory Asset Management (BMRAM) systems preferred.
- Fluent in Microsoft Office programs.
- Strong written communication skills and understanding of Good Documentation Practices (GDP).
