Process & Validation Engineer

Job-ID27403841Reference24-00787 Responsibilities: Write and execute commissioning, qualification, & validation protocols for facilities, utilities, and process equipment. Oversee and review design and construction work related to cGMP manufacturing facility. Review submittals, IOM, control sequences, and start up procedures. Perform Walk Downs of As-Built P&IDs and Redlining P&IDs as required. Document and manage all punch lists and deviations. Write and review deviations, CAPAs, Change Controls, etc. Perform basic revisions as needed to accurately reflect current procedures. Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE) i.e., scrubs, gowning coverall, masks, gloves, etc. Work in both an office and a manufacturing lab setting. Work in a lab setting with various chemical/biochemical exposures, including latex and bleach. Work in a cleanroom with biohazards, human blood components, and chemicals. Support project management initiatives to ensure efficient and timely progress. Additional relevant duties as needed.