Senior Commissioning Engineer - Framingham, United States - TalentBurst

Description

Position: Principal Commissioning/Validation Engineer III, Req#: SNFIJP

Location: Framingham, MA (100% onsite)

Duration: 6 Months Contract

Job Description:

Education and Experience:

• BSc/BEng plus previous experience in the CQV field or equivalent combination of education and experience.
• Experience in the 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.
• 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

Roles and Responsibilities:

• Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems
• Writes final reports
• Resolves protocol discrepancies and deviations
• Review 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.