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Sr. Validation Engineer

4 months ago

Nashville, United States August Bioservices Full time

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 Sr Validation Engineer team member that is passionate and driven regarding their work. August Bioservices needs a motivated individual to provide their expertise in the delivery of results for the company and its clients.

Reporting to the Director of Validation and Metrology, the Sr Validation Engineer will be responsible for performing validation related tasks for the Nashville site. The Sr. Validation Engineer independently performs validation tasks to serve company and customer needs and to follow cGMPs.

Responsibilities

    • Prepares validation protocols (IQ/OQ/PQ) and final reports for equipment and processes to assure they are in compliance with Code of federal regulations, (CFR), International Society for Pharmaceuticals Engineering (ISPE), and Aseptic Processing Guidance.
    • Will prepare and or review the User Requirement specifications, System Impact assessments, Design Specifications, Enhanced design reviews, and 21 CFR assessments.
    • Will be the validation lead for major site validation projects such as: equipment cleaning, cleanroom qualification, sterilizers, automated filling machines, utilities, WFI, and clean steam,
    • Will participate in Factory Acceptance testing and Site Acceptance testing,
    • Oversees and executes validation and re-validation studies
    • Develops validation acceptance criteria
    • Represents validation in agency and customer audits as an SME.
    • Writes and revises, validation master plans, work instructions, and Standard Operating Procedures (SOPs);.
    • Recommends validation procedural and test improvements
    • Maintain current validation project schedules
    • Provide training for both team validation members and 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
Requirements
    • BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering or other related discipline
    • 5+ years of experience with BS in Pharmaceutical, Biological or Biotech industry; hands-on experience in manufacturing operations or pilot lab / scale-up operations
    • Excellent verbal and written communication skills


At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule - from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.