Quality Engineer II

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
• Direct hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)

• Project management skills not required but preferred.
• Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles
• Ability to provide QA oversight for the implementation, maintenance, and enhancement of a LIMS system, ensuring the system remains in a validated state throughout its lifecycle.
• Ability to apply validation engineering principles to the design and implementation of projects
• Knowledge of IT infrastructure and information database systems
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
• Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
• Advanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)
• Excellent written and verbal communication skills
• Versatility, flexibility, and willingness to work within constantly changing priorities
• Ability to deal effectively with a diversity of individuals at all organizational levels

• This position has no supervisory responsibility

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

• Primarily office
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

• This is a full-time position
• Some flexibility in hours is allowed, by the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.