Title: Principal Commissioning/Validation Engineer III
Location: Framingham MA
Duration: 06 months contract (Chances of extension)
Requirements:
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. Welldeveloped communication skills both verbal and written.
Min Education:
Bachelors degree
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 daytoday operations in a fastpaced environment
Ability to effectively manage several tasks simultaneously
Must be selfmotivated and have a proven ability to work in a team environment