Validation Engineer

August Bioservices•Nashville, TN

25d•Onsite

About The Position

August Bioservices is looking for a Validation Engineer team member that is passionate and driven regarding their work. August Bioservices is in need of a motivated individual to provide their expertise in the delivery of results for the company and its clients. Reporting to the Supervisor of Validation, the Validation Engineer will be responsible for performing validation related tasks for the Nashville site. The Validation Engineer independently performs validation tasks to serve company and customer needs and to be in compliance with cGMPs.

Requirements

BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering or other related discipline.
Excellent verbal and written communication skills

Nice To Haves

2-5 years of experience with BS in Pharmaceutical, Biological or Biotech industry
hands-on experience in manufacturing operations or pilot lab / scale-up operations

Responsibilities

Prepares validation protocols (IQ/OQ/PQ) and final reports for equipment and processes
Oversees validation and revalidation studies for protocol compliance
Develops validation acceptance criteria
Performs validation fieldwork on an as-needed basis
Writes and revises Standard Operating Procedures (SOPs)
Recommends validation procedural and test improvements
Plan, track, and perform validation projects
Maintain current validation project schedules
Provide training for contract validation personnel
Review critical equipment drawings from a Validation perspective
Review and summarize equipment history files to assess the validated state of equipment
Proactively identifies potential obstacles to successful project completion. Establishes remediation plans to overcome these obstacles
Participates as validation representative on failure investigation teams