AMVETS Jobs

JOB REQUIREMENTS: Job Description OUR TEAM: We are the Operations Validation Team. We are made up of different specialists who play multiple roles: statistical data scientists, process validation engineers, analytical method validation engineers. We provide our expertise in all things Validation to Promega. We lend our expertise to validating products, processes, analytical methods, and qualifying equipment that supports our Class 1 Medical Devices. Our diverse internal clientele includes all areas of Promega\'s Bulk Manufacturing, Customs Manufacturing and R&D business units. YOUR ROLE: Lead and execute validation and qualification activities of equipment and processes while working in a team environment. Independently draft, review, execute validation and qualification protocols per industry practices and internal guidelines. The position requires working knowledge and experience in the qualification of bulk manufacturing process equipment and facilities utilities. Experience with equipment and process validation is highly desirable. JOB OBJECTIVE: Manage and Perform the Process Validation activities for all manufacturing equipment, manufacturing processes, facilities and critical utilities. CORE DUTIES: 1. Work independently and collaboratively. Characterize process performance as needed. Develop validation procedures. Guide the determination of acceptance criteria for validation and qualification protocols. 2. Work with the Operations, Engineering, and Validation Team to produce resource estimates and schedules for the process validation tasks on projects. Manage schedule activities for successful completion of validation tasks. Assist Project Managers in developing the validation planning portions of project plans, and in scoping the resources required for successful implementation of validation tasks. 3. Create or revise Validation Master Plans and other Validation planning documents where appropriate. 4. Responsible for preparation and execution of process validation test procedures and acceptance criteria for process equipment, facilities, and critical utilities validation protocols. 5. Work directly with equipment vendors to assist them in development of process design and validation documentation, and in facilitating review/approvals within Promega. 6. Serve as or assist Validation Lead in turnover of validated systems to process owners. Evaluate and support changes to validated systems. 7. Supervise validation contract personnel in planning and completion of process validation tasks. 8. Serve as process validation expert resource for Promega in the IVD (21 CFR Part 820) regulated industry. 9. Serve as technical resource for... For full info follow application link. Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/825A62F6E3274B8C Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.