•B.S. (or equivalent 4-year degree) in Engineering or Science
•5 or more years validation experience in GMP Pharmaceutical manufacturing environment
•Experience preparing/authoring technical documentation / validation protocols.
•Effective communication - both verbal and written
•Demonstrated collaboration and teamwork skills
•Demonstrate project management skills
•Strong Temperature Mapping Background (Kaye Validator/ Valprobes)
•Previous experience with biologicals and/or vaccines
•Previous experience with sterilizers, controlled temperature units, Temperature mapping, and/or computer automation.
1. Author technical documents such as protocols, feasibility studies, and deviation investigations that align with corporate standards and industry requirements.
2. Adhere to Change Control procedures and ensure processes are maintained in a validated state through recertification / re-validation activities.
3. Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues.
4. Partner (collaborate) with other internal departments (Operations, Quality, Plant Engineering, and Technology), and external centers of excellence (COEs) on process or validation related activities/events.
5. Conduct equipment/system reviews.
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