Validation Engineer
Bright Path Labs Kannapolis, NC Full-Time
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Job Details
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Validation Engineer
at Bright Path Laboratories, Inc
The Company
Bright Path Laboratories, Inc. (BPL) is a leading U.S.-based advanced drug development and manufacturing company that has answered the call to recast Americas reliance on foreign pharmaceutical ingredients and medicines using patented AI-enabled continuous flow technology.
Founded in 2017, BPLs game-changing platform drives rapid synthetic route development and highly automated, controlled, and inexpensive deployment of scaled cGMP commercial manufacturing enabling the manufacture of Active Pharmaceutical Ingredients (APIs) and specialized medicines (e.g., orphan drugs to treat patients with rare diseases) here in the United States. It is estimated that the U.S. imports 80% of the APIs it uses for medicines and BPL is uniquely positioned to reduce our dependency on foreign suppliers and securitize Americas pharmaceutical supply chain.
The Opportunity
Delivering medicines and APIs of the highest quality is critical to our success and our new Computer Systems Validation (CSV) Engineer will ensure that our systems and procedures used in the development and production of our pharmaceutical products are appropriately calibrated and meet cGMP requirements. This role is hands-on, highly cross-functional, and works closely with various business stakeholders to ensure cGMP compliance.
Specific responsibilities will include, and are not limited to:
• Oversee the execution of qualification/validation activities for our computer systems, equipment controls, new software implementations, and utilities.
• Author, review and approve qualification/validation documentation (e.g., specifications, protocols, engineering change notices, etc.) and ensure compliance with the FDAs GLP and GMP regulations.
• Assess client computer systems and identify any potential Part 11 gaps and ensure data integrity best practices are implemented.
• Work closely with the QA function to provide expertise in CSV (computer system validation) compliance, manage identified issues, and support continuous improvement.
• Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Provide input to GxP assessments for 21 CFR Part 11/Data Integrity requirements.
• Develop and maintain databases for tracking test results, validation activities, or validated systems.
• Perform risk assessments with functional teams to assess system risks and develop mitigation plans.
• Review off-the-shelf software and software systems used in quality processes to determine appropriate validation requirements.
• Perform other related duties as assigned.
Preferred qualifications
• Minimum of a bachelors degree in Computer/Information Systems, Engineering, Science, or equivalent combination of education and CSV experience required.
• 2-5 years of experience working in a cGMP environment in Quality Compliance or Computer System Validation required.
• Strong knowledge of FDA regulations regarding CSV with experience in 21 CFR Part 11 required.
• Experience in authoring/reviewing/approving validation documentation required.
• Excellent written and verbal communication skills with ability to work with cross-functional teams.
• Self-starter with the ability to manage multiple projects and drive to completion.
• Excellent people skills with a high level of emotional intelligence.
• Thorough understanding of applicable mathematics and scientific practices.
• Proficient with Microsoft Office Suite or related software.
Compensation & benefits
• Great colleagues
• Competitive salaries
• Stock compensation plan you will be a Bright Path Labs co-owner
• Health, dental, and vision benefits
• Remote/commute work schedule available
Bright Path Labs is not currently offering visa sponsorships for any position. Please only apply if eligible to work in the U.S.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, or veteran status.
Recommended Skills
• Api
• Assessments
• Business Process Improvement
• Communication
• Databases
• Emotional Intelligence
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