Sr. Validations Specialist

Job description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary: The Sr. Validations Specialist is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation of equipment and GxP computerized systems. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, manufacturing equipment, conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; ensuring compliance with 21 CFR Part 11, Data Integrity, and functional requirements; developing documentations as required for projects; serve as the subject matter expert during audits and inspections and consulting on validation and cGMP questions and issues. The ideal candidate will work on extremely complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. On-Site...