Principal Commissioning/Validation Engineer III

BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience. Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment. Areas of experience: plant utilities, clean utilities, CIP, SIP, Fill Finish, HVAC, Filling lines, CTUs, component prep equipment, formulation. Well-developed communication skills, both verbal and written.

Essential Duties and Responsibilities:
Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems
Writes final reports
Resolves protocol discrepancies and deviations
Reviews vendor generated validation protocol packages
Responsible for the generation of complex protocols using a risk based approach that meets current regulatory requirements and industry practices

Other Skills and Abilities:
Excellent oral and written communication
Ability to effectively manage time and prioritize tasks independently
Excellent organizational skills
Ability to manage day-to-day operations in a fast-paced environment
Ability to effectively manage several tasks simultaneously
Must be self-motivated and have a proven ability to work in a team environment
Min Education Bachelors degree