Principal Commissioning/Validation Engineer III

4 weeks ago


Framingham, United States TalentBurst, an Inc 5000 company Full time

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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