Principal Commissioning/Validation Engineer III
4 weeks ago
Industry: Biotechnology
Position: Principal Commissioning/Validation Engineer III
Location: Framingham, MA - 01701
Duration: 06 months contract (+Possibility 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. Well-developed communication skills, both verbal and written. Years of Experience: 6 - 9 Years.
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
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