Quality Engineer II

At Bio Agilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best‑in‑class bioanalytical services. We are tirelessly committed to our customers by being solution‑oriented and deadline‑driven. . . and we are growing. Our culture is fast‑paced, fun and never boring.

Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life‑changing, life‑saving therapeutics to the patients who need them.

The Quality Engineer II is responsible for providing quality assurance (QA) oversight of computer validations and equipment qualifications. He or she is responsible for maintaining a strong collaborative partnership with cross‑functional team members that facilitates organizational success and meets business needs.

• Provides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security)
• Ensures all activities related to applicable computer systems and equipment qualifications are in compliance with national/international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs
• Performs the quality review of SOPs, policies, and the computer validation and equipment qualification master plan, as required
• Responsible for QA oversight of the computer system validation and equipment management programs as well as working with other departments/consultants/vendors to plan, implement, and complete all validation/qualification projects (e.g. LIMS, ELN, QCBD, equipment software, etc.)
• Responsible for system administration of Quality Management Systems (e.g. ZenQMS, Blue Mountain)
• Responsible for electronic Archives oversight
• Responsible for the maintenance of the Computer System Validation Status listing and Equipment Master Listing
• Reviews and approves equipment out of tolerances investigations
• Performs vendor qualification of vendors, contractors, consultants, and technicians that will participate in computer validation/equipment qualification activities
• Confirms periodic reviews of validated computer systems and equipment are performed, including reviewing periodic reviews and confirm all required follow‑up actions are completed
• Responsible for QA review and approval of validation documentation for new and existing computer systems/equipment subject to validation
• Reviews and approves for QA, deviations incident reports for executed validation and qualification documents. Ensures assignable causes are identified and addresses corrective actions, as needed
• Serves as QA representative for the testing of the Business Continuity (e.g. IT testing) and computer system validations and equipment qualification during regulatory agency and sponsor inspections
• Responsible for QA review and approval of change controls and Out of Tolerances to ensure timely closure
• Perform duties with minimal QA Engineer Management oversite

• Other duties as needed

• Bachelor’s degree in engineering, information technology, computer science, or related discipline
• Not less than five (5) years’ experience in pharmaceutical/GxP/regulated environment
• Direct hands‑on experience with computer systems validation and/or equipment qualifications

• Project management skills not required but preferred.
• Knowledge of and technical competency in GAMP guidelines and evaluating systems…