Description
Educational Requirements:The candidate must have a BS/BA in chemical engineering, chemistry, biology, microbiology or an engineering/scientific discipline.Experience Requirements: The candidate must have a minimum of 3 years validation experience in the regulated life sciences industry. The successful candidate will have a sound knowledge and understanding of cGMP regulations and industry standards. Above average proficiencywith MS Word, Excel and Visio are required.
Interpersonal Profile Requirements: The candidate must be self starter, be able to think on their feet, have a strong sense of accountability and be comfortable with a fast moving environment. The individual must have outstanding written and verbal skills, accompanied by strong interpersonal skills and the ability to communicate effectively and efficiently with clients and internal project personnel.
Responsibilities:Duties include preparing schedules and executing validation protocols. Design of testing strategy and methodology for the qualification and validation of products and cleaning processes. Preparing final reports following execution. Reviewing Standard Operating Procedures (SOP's) and to ensure the operational directions and parameters described in the SOP for the equipment reflects validated conditions. Support quality investigations resulting from process deviations and provide CAPA support, if necessary.
Requires dedication and flexibility to conform to a work schedule in which the start times may vary extremely. Must be flexible and able to work off-shifts, holidays and weekends as validation execution schedule requires; this may include periodically working 2nd or 3rd shifts to meet aggressive timetables.