Validation Engineer
- Location: Montgomery County, MD
- Type: Contract
- Job #38238
Accountabilities:
- Performs installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems.
- Responsibilities include newly installed equipment and systems as well as previously qualified equipment and systems, which are modified through Change Control and periodic assessments of equipment, facilities, and utility systems.
- Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and executes protocols.
- Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
- Performs fieldwork such as checking systems and equipment that are located in manufacturing areas.
- Maintains and enhances reliable and responsive working relationships with internal and external customers and suppliers.
- Participates in the validation activities associated with all Quality Investigations.
Qualifications:
- Bachelor’s degree required, preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences.
- 1-3 years of relevant validation experience in the pharmaceutical industry.
- Knowledge and understanding of validation and qualification principles, project management, and change control principles.