---
title: 'Quality Engineer II at BioAgilytix'
canonical: 'https://feeny.ai/job/quality-engineer-ii-bioagilytix-durham-wrbv8q6nqdpm'
type: 'job'
last_seen: '2026-09-11'
---

# Quality Engineer II at BioAgilytix

- **Company:** BioAgilytix
- **Location:** Durham, NC
- **Work type:** onsite
- **Posted:** 2026-09-10
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/bioagilytix/b36c396a-51a6-4891-9e4e-3b2ff3e3f5a6

## Job description

At BioAgilytix, 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.

Essential 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

Additional Responsibilities

- Other duties as needed

## Minimum Preferred Qualifications - Education/Experience

- 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)

## Minimum Preferred Qualifications - Skills

- 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

Supervisory Responsibility

- This position has no supervisory responsibility

Supervision Received

- Infrequent supervision and instructions
- Frequently exercises discretionary authority

Working Environment

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

Position Type and Expected Hours of Work

- 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

## BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program

## COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

To learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use.

## About BioAgilytix

## Company Overview
- **One-liner**: BioAgilytix is a global contract research organization providing GxP-compliant bioanalytical testing services to support pharmaceutical and biotech partners in all phases of drug development.
- **Entity Type**: Private (funded)
- **Headquarters**: Durham, North Carolina, United States
- **Founded**: 2008
- **Founders**: Not publicly available

## Core Business
- **Primary Industry**: Biotechnology Research / Bioanalytical Contract Research Organization (CRO)
- **Target Customers**: B2B; specifically top pharmaceutical and biotechnology companies developing cutting-edge therapies.
- **Mission or Purpose Statement**: To deliver innovative and reliable bioanalytical testing solutions, providing data and insight which lead to better, faster decisions on drug candidates in development.

## Products & Services
BioAgilytix offers a comprehensive suite of laboratory services, primarily conducted under non-GLP, GLP, GCP, and GMP quality control testing:
- **Pharmacokinetics (PK) Services**: Assay development, validation, and sample testing for small molecules, large molecules, and advanced drug modalities.
- **Immunogenicity Services**: Screening, characterization, and neutralizing antibody assays to optimize drug safety, leveraging deep expertise in unwanted biotherapeutic-induced immunogenicity.
- **Biomarker Analysis**: Fit-for-purpose biomarker assay development and testing from a menu of over 120 off-the-shelf assays, supporting clinical trial efficacy and safety.
- **CMC Analytical Services**: Cell-based potency assays, molecular assays, mass spectrometry characterization, and other analytical methods supporting therapeutics from pre-IND to commercial release testing.
- **Diagnostic Testing Services**: Offered at its CLIA-certified, CAP-accredited Boston laboratory.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private company)
- **Key Metric**: Annual Revenue of **$130M**; **$30.1M** in total funding from one prior round.
- **Notable Investors/Partners**: Not specifically named in available sources. They support 21 of the world’s top 25 biopharma companies and supported ~30% of FDA-approved biologics from 2020 to 2024.
- **Growth Signals**:
    - **1,100+ employees**, with a headcount growth of 2.1% YoY (+19 people) to 698 (according to LinkedIn, which may be lower than the company's self-reported total).
    - **Industry-leading employee retention rate of 90%**.
    - Global presence with labs in Durham, NC; Boston, MA; San Diego, CA; Hamburg, Germany; Melbourne and Brisbane, Australia; and partner labs in Beijing, China.

## Competitive Advantages
- **World-Class Expertise**: Over 50% of scientists hold PhD and/or master’s degrees; the science team averages over 10 years of bench experience.
- **Proven Track Record**: Supported ~30% of FDA-approved biologics between 2020 and 2024 and works with 21 of the top 25 global biopharma companies.
- **Global Scale & Local Reach**: Operates in key biopharma hubs across the US, Europe, and Australia, with partner labs in China, enabling seamless global study transitions.
- **High Retention**: A 90% employee retention rate indicates strong workplace satisfaction and internal stability.
- **Comprehensive Capabilities**: Offers an "industry’s most complete set of capabilities," from assay development to commercial batch release, providing a consultative, scientist-to-scientist partnership model.

## Strategic Focus
Based on available materials, BioAgilytix is focused on continued expansion of its global footprint (notably in Australia and Europe), deepening its expertise in advanced drug modalities (cell and gene therapies, oligonucleotides), and maintaining its leadership in bioanalysis for biologics. Its strategic focus is to proactively anticipate assay challenges to keep partner drug development timelines on track.

## Why Work Here
- **Culture & Mission**: BioAgilytix fosters a culture of diversity, equity, and inclusion, supported by employee resource groups (ERGs). Employees solve "mission-critical bioanalytical solutions" that help bring therapies to patients faster.
- **Work Policy**: Roles are **on-site** at specific lab locations (e.g., San Diego, CA; Melbourne, Australia; Durham, NC). This is a lab-based scientific organization.
- **Benefits (US)**: Competitive compensation, health/dental/vision insurance, 401(k) savings plan, paid time off, paid parental leave, short- and long-term disability, group life insurance, employee assistance programs, adoption and fertility support, pet insurance, and legal assistance.
- **Professional Development**: Access to high-visibility industry forums, continuous learning platforms, and opportunities to work on cutting-edge therapies for the world’s top pharma companies.

## Sources
1. [bioagilytix.com](https://www.bioagilytix.com/)
2. [bioagilytix.com - Careers](https://www.bioagilytix.com/about/careers/)
3. [bioagilytix.com - Corporate Brochure](https://www.bioagilytix.com/wp-content/uploads/2026/03/BioAgilytix-Corporate-Brochure-March-2026.pdf)
4. [linkedin.com](https://linkedin.com/company/bioagilytix)
5. [jobs.lever.co](https://jobs.lever.co/bioagilytix)

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