A BDN client is looking for three (3) well-rounded validation contractors versed in Test Method, Process, Equipment, Facility and Utility Validation. They will be supplementing the client’s full-time staff in supporting the validation team primarily in the aforementioned areas. Work will include protocol review & development, execution, final report writing and the review of calibration documentation. The validation life cycle process shall include Design Qualification Generation/Approval, Protocol Generation/Approval, Protocol Execution, Protocol Discrepancy Resolution and Final Report Preparation for Approval. The individuals may be required to support the ongoing site and/or Division Projects. However, primary duties will be to support the site validation activities. Training on client procedures and access to required IT systems will be provided along with the use of a client issued computer. Templates will be provided for all required validation deliverables. Typical deliverables and validation activities may include: Design Qualification (DQ): URS, pFMEA, CFR 21 Part 11 Compliance Assessment, Tracematrix, FAT, SAT support (Plan development and verification), Equipment IQ/OQ, Process Characterization (protocol(s) development, execution and final report(s)), Worst Case Process OQ, and Manufacturing and Cleaning Validation (Performance Qualification).