Quality Engineer II — Computer Systems Validation

BioAgilytix; United States; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401k with Employer Match

Paid Time Off & Holidays

Job summary

BioAgilytix is seeking a seasoned QA professional to lead computer system validation and equipment qualification efforts in a fast-paced, regulated environment. You will oversee implementations, maintain validated states across systems like LIMS, and coordinate with multiple teams to meet regulatory expectations.

Responsibilities include ensuring compliance with 21 CFR Part 11, Annex 11, and GAMPs, reviewing validation documents, and supporting vendor qualification and IT infrastructure efforts

Qualifications

• Bachelor’s degree in engineering, IT, CS, or related discipline.
• Five or more years’ experience in pharmaceutical/GxP environments.
• 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, ISO).

Responsibilities

• Provide QA oversight for the validation of computer systems and equipment.
• Ensure activities comply with GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs.
• Review and approve SOPs, policies, and validation documentation.
• Serve as QA representative for testing Business Continuity and regulatory inspections.
• Review changes and out-of-tolerances to ensure timely closure.
• Perform vendor qualification activities for QA projects.
• Maintain QA systems and electronic archives oversight.

Skills

GAMP guidelines

LIMS QA oversight

Validation engineering

IT infrastructure

Learning agility

Fast-paced environment

MS Office

Communication skills

Adaptability

Stakeholder management

Project management

Education

Bachelor’s degree in engineering/IT/CS

Tools

LIMS

QCBD

ZenQMS

Blue Mountain

Job description

BioAgilytix is seeking a seasoned QA professional to lead computer system validation and equipment qualification efforts in a fast-paced, regulated environment. You will oversee implementations, maintain validated states across systems like LIMS, and coordinate with multiple teams to meet regulatory expectations.

Responsibilities include ensuring compliance with 21 CFR Part 11, Annex 11, and GAMPs, reviewing validation documents, and supporting vendor qualification and IT infrastructure efforts