Title: Validation Engineer
Location: Royston, GA
Industry: Pharmaceutical
DSJ Global is partnered with an industry leading pharmaceutical company who is looking to add a Validation Engineer to their team. The Validation Engineer will lead activities to develop and improve manufacturing processes by studying product and manufacturing methods, preparing analyses reports, presenting information and making recommendations to solve problems and/or improve processes.
The Validation Engineer will be responsible for:
1. Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
2. Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
3. Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
4. Develops and maintains databases for tracking test results, validation activities, or validated systems.
5. Equipment Qualification - development of validation protocols, testing execution and writes validation reports. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, and other validation life cycle documents.
6. Adhere to all company and GMP procedures, along with safety regulations within the plant.
7. Assist with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.
8. Stay current with industry qualification trends through FDA, ISPE, EU, PDA and bench marked companies.
The Validation Engineer should have:
9. Bachelor's degree in related field required.
10. 3 years of experience as manufacturing or validation engineer
11. 3 year of experience in cGMP environment
12. 3 years of experience in oral solid dose, compression, encapsulation, powder filling, and/or tableting