Augustbioservices12d ago

Validation Engineer

United States·NashvilleFull-Timemid

QA & TestingValidation Engineer

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Quick Summary

Requirements Summary

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

Technical Tools

QA & TestingValidation Engineer

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

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.

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; and

Participates as validation representative on failure investigation teams.

•BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering or other related discipline.

Excellent verbal and written communication skills

Preferred Qualifications:

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