Quality Engineer II — Computer System Validation

BioAgilytix Labs, LLC; Durham, Northern (NC, KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

401k Match

Paid Time Off

Parental Leave

Paid Holidays

Dental Insurance

Vision Insurance

Flexible Spending Account

Job summary

BioAgilytix Labs, LLC is seeking a Quality Engineer II to provide QA oversight of computer system validations and equipment qualifications in a fast-paced biotech environment.

The role requires collaboration with multiple teams to ensure GxP compliance, review validation docs, and manage QA processes across systems and equipment. A bachelor’s degree and 5+ years in regulated pharma are required.

Qualifications

• 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).

Responsibilities

• 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

Skills

GxP regulations

QA oversight

CS validation

Documentation

Vendor qualification

Regulatory inspections

Project management

Education

Bachelor's degree

Tools

LIMS

ELN

QCBD

ZenQMS

Blue Mountain

Job description

BioAgilytix Labs, LLC is seeking a Quality Engineer II to provide QA oversight of computer system validations and equipment qualifications in a fast-paced biotech environment.

The role requires collaboration with multiple teams to ensure GxP compliance, review validation docs, and manage QA processes across systems and equipment. A bachelor’s degree and 5+ years in regulated pharma are required.