Industry: Biotechnology
Position: Principal Commissioning/Validation Engineer III
Location: Framingham, MA - 01701
Duration: 06 months contract ( Possibility of extension)

• 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.
• Years of Experience: 6 - 9 Years.

• 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

• 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