B

BioAgilytix

Global bioanalytical testing for drug development

Quality Engineer 2

Full-Time
No salary listed
Senior
Bachelor's
Durham, NC, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • Bachelor’s degree in engineering, information technology, computer science, or a related discipline.
  • At least five years of experience in a pharmaceutical, GxP, or regulated environment.
  • Direct hands-on experience with computer systems validation and/or equipment qualifications.
  • Direct hands-on experience with GxP regulations, including FDA, EPA, EU, ICH, USP, ASTM, and ISO.
  • Knowledge of GAMP guidelines and evaluating systems lifecycle principles.
  • Ability to provide quality assurance oversight for the implementation, maintenance, and enhancement of a LIMS system while keeping it in a validated state throughout its lifecycle.
  • Ability to apply validation engineering principles to project design and implementation.
  • 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 and policies.
  • Ability to work in a fast-paced environment with multiple projects that must be completed in a timely manner.
  • Advanced computer skills in Microsoft Office, including Word, Excel, and Outlook.
  • Excellent written and verbal communication skills.
  • Versatility, flexibility, and willingness to work within changing priorities.
  • Ability to deal effectively with diverse individuals at all organizational levels.
Responsibilities
  • Provide quality assurance guidance in developing and revising computer system and equipment procedures and policies, including validations, change control, and security.
  • Ensure activities related to applicable computer systems and equipment qualifications comply with national and international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs.
  • Perform quality reviews of standard operating procedures, policies, and the computer validation and equipment qualification master plan.
  • Provide quality assurance oversight of computer system validation and equipment management programs, and work with departments, consultants, and vendors to plan, implement, and complete validation and qualification projects, including LIMS, ELN, QCBD, and equipment software.
  • Administer Quality Management Systems such as ZenQMS and Blue Mountain.
  • Provide oversight of electronic archives.
  • Maintain the Computer System Validation Status listing and Equipment Master Listing.
  • Review and approve equipment out-of-tolerance investigations.
  • Perform vendor qualification for vendors, contractors, consultants, and technicians participating in computer validation and equipment qualification activities.
  • Confirm periodic reviews of validated computer systems and equipment are performed, review those periodic reviews, and confirm required follow-up actions are completed.
  • Review and approve validation documentation for new and existing computer systems and equipment subject to validation.
  • Review and approve deviations and incident reports for executed validation and qualification documents, ensure assignable causes are identified, and address corrective actions as needed.
  • Serve as the quality assurance representative for business continuity testing, computer system validations, and equipment qualification during regulatory agency and sponsor inspections.
  • Review and approve change controls and out-of-tolerance items for quality assurance to ensure timely closure.
  • Perform duties with minimal quality assurance engineering management oversight.
  • Work occasional weekend, holiday, and evening hours as required.
Desired Qualifications
  • Project management skills are preferred.

About the company

BioAgilytix is a global bioanalytical laboratory that provides testing services for pharmaceutical, biotechnology, and agricultural biotech companies, with a notable presence in Hamburg, Europe. It specializes in large-molecule studies and runs assays such as pharmacokinetics, pharmacodynamics, cell-based tests, and immunogenicity to measure how drugs behave in the body and assess safety and efficacy. The company offers customizable, service-based testing that supports drug development from research through regulatory approval, including COVID-19 testing packages. Its differentiators are its global reach, deep expertise in large-molecule workflows, and a flexible model that partners with clients on a project basis. Its goal is to deliver precise, validated bioanalytical data that helps clients develop and bring new therapies to market.

Company Size

501-1,000

Company Stage

Growth Equity (Venture Capital)

Total Funding

$30.1M

Headquarters

Durham, North Carolina

Founded

2008

Get referred to BioAgilytix

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • Lexeo’s February 2026 gene-therapy program elevates BioAgilytix into premium regulatory work.
  • May 2026 Morrisville GMP expansion increases capacity for higher-margin QC testing.
  • Hamburg regained French CIR approval in 2026, supporting European commercial credibility.

What critics are saying

  • BioAgilytix sued ex-executive James McNally in April 2025 over trade secrets.
  • Revelio shows 2026 active postings fell 46.8%, signaling slower hiring momentum.
  • Heavy private-equity ownership from Cinven and Cobepa pressures margin expansion and exit timing.

What makes BioAgilytix unique

  • FDA granted BioAgilytix Breakthrough Device Designation for AAVrh.10 assay in February 2026.
  • BioAgilytix runs 355,000 square feet across Durham, Hamburg, and Australia.
  • Its 2025-2026 LC/MS investments strengthened global bioanalysis and CMC analytical services.

Help us improve and share your feedback! Did you find this helpful?

Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • Disability Insurance
  • Health Savings Account/Flexible Spending Account
  • Unlimited Paid Time Off
  • Paid Vacation
  • Paid Sick Leave
  • Paid Holidays
  • 401(k) Company Match
  • Parental Leave

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

1%
Ochre Digi Media Pvt. Ltd.
Oct 13th, 2026
BioAgilytix expands global bioanalytical capabilities with new Sydney laboratory.

BioAgilytix expands global bioanalytical capabilities with new Sydney laboratory. Tuesday, October 13, 2026 BioAgilytix, a global leader in bioanalytical services, announces the opening of a new laboratory in North Ryde, Sydney, through 360biolabs, its Australian laboratory business. The expansion extends BioAgilytix's bioanalytical footprint across Australia, Europe and the United States. The laboratory is located in Sydney's Macquarie Park Innovation District, a major New South Wales science, health and technology precinct near clinical trial units, hospitals, research organizations and participant populations. With locations in Melbourne, Brisbane and Sydney, 360biolabs gives sponsors access to bioanalytical support across Australia's eastern states, where much of the country's clinical research infrastructure and population base is concentrated. The Sydney laboratory has been purpose-built for time-sensitive clinical trial samples and complex early-phase study requirements. Initial capabilities in the BSL-2 laboratory space include PBMC isolation, flow cytometry, sample reception and storage, ULT freezer capacity, vapour-phase nitrogen cryostorage, and 24/7 temperature monitoring. For sponsors planning first-in-human and early clinical studies, the expansion supports a practical development model: generate early data in Australia, then maintain scientific and operational continuity as programs advance into later-phase global development. "Australia is a primary destination for early-phase clinical research, supported by a streamlined regulatory pathway, rapid study start-up timelines and R&D tax incentives for eligible sponsors," said Davide Molho, CEO of BioAgilytix. "The new Sydney laboratory expands BioAgilytix's Australian footprint through 360biolabs, alongside Melbourne and Brisbane, and strengthens our ability to support sponsors as their programs advance across global regions." Australia can support efficient early-phase clinical study execution through its recognised quality standards, practical regulatory environment, cost efficiency for eligible sponsors and data utility when studies are conducted to accepted requirements. The Sydney expansion reinforces BioAgilytix's ability to support sponsors seeking a coordinated pathway from first-in-human studies through global development. "Sydney allows us to invest alongside the growth in Australia's clinical trials infrastructure. It expands our ability to support clients locally, strengthens our national business and creates a stronger foundation for continued growth in the region." said Alistair Draffan, President of 360biolabs. 360biolabs is accredited by Australia's National Association of Testing Authorities (NATA) for compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and ISO/IEC 17025. This accreditation supports sponsors seeking recognised quality standards for early-phase studies conducted in Australia. The Sydney laboratory extends BioAgilytix's global network and strengthens its ability to support sponsors with local expertise and continuity across regions as programs progress. About 360biolabs 360biolabs is Australia's most comprehensive bioanalytical laboratory, supporting the development of therapeutics, vaccines and diagnostics. With laboratories in Melbourne, Brisbane and Sydney, 360biolabs supports clinical studies across PK, PD, immunogenicity, biomarkers, vaccines, infectious diseases, flow cytometry, molecular biology and central laboratory services. 360biolabs is accredited by Australia's National Association of Testing Authorities (NATA) for compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and ISO/IEC 17025. About BioAgilytix BioAgilytix is a global bioanalytical laboratory partner supporting biopharmaceutical and biotechnology companies across every phase, every modality. Through its global laboratory network in Australia, the United States and Europe, BioAgilytix provides integrated scientific and operational support for complex clinical development programs. Media Contact Bernice Averion Marketing and Communications Manager, 360biolabs [email protected]

BioAgilytix
Mar 24th, 2026
BioAgilytix celebrates Jessica Bridges Weaver for scientific leadership with 2026 TBJ Award.

BioAgilytix celebrates Jessica Bridges Weaver for scientific leadership with 2026 TBJ Award. Durham, N.C. - March 24, 2026 - BioAgilytix, a global leader in bioanalytical services, is proud to celebrate its commitment to scientific excellence and leadership with Jessica Bridges Weaver, Scientific Officer, who has been named a 2026 Triangle Business Journal Women in Business Award Winner. With more than 20 years of experience across pharmaceutical manufacturing and analytical testing, Jessica has played a critical role in strengthening BioAgilytix's scientific and regulatory leadership. In her role, she partners closely with global laboratory and business development teams to advise clients on phase-appropriate, regulatory-ready testing strategies for complex biologics. Her work extends to assay design and troubleshooting, ensuring methods align with both client objectives and evolving global regulatory expectations. Her impact has been especially evident in the strategic expansion of BioAgilytix's CMC analytical testing services in the Research Triangle Park hub, as well as the global growth of GMP bioassay capabilities and the development of specialized infrastructure in Hamburg, Germany. Beyond operational leadership, Jessica is a recognized thought leader in CMC analytics and bioanalysis who produces and delivers webinars, conference presentations, and peer-reviewed publications that promote continuous learning and knowledge-sharing across the life sciences community. "Jessica exemplifies the scientific rigor, integrity, and collaborative leadership that defines BioAgilytix," said Davide Molho, Chief Executive Officer of BioAgilytix. "Her ability to translate complex science into meaningful impact for our clients and the industry makes her an outstanding leader and a deserving recipient of this recognition." In addition to her professional achievements, Jessica is deeply committed to community service and mentorship. She actively supports STEM education initiatives, mentors high school students, and partners with organizations focused on pediatric care and child welfare. Her work reflects a lifelong commitment to stewardship, integrity, and expanding access to opportunities for future generations. "It is truly an honor to be recognized alongside so many inspiring women," said Jessica Weaver. "This recognition reflects the incredible teams I am privileged to work with at BioAgilytix and our shared commitment to advancing science, strengthening communities, and improving patients' lives. I am grateful for the opportunity to contribute to work that creates meaningful impact for our clients and the broader life sciences community." Jessica's recognition represents the strength of the BioAgilytix community, and a culture built on collaboration, integrity, and scientific excellence. About BioAgilytix BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalytical laboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in a GxP environment. BioAgilytix maintains state-of-the-art laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany. For more information, please visit www.bioagilytix.com.

Associated Press
Feb 10th, 2026
BioAgilytix receives FDA breakthrough device designation for anti-AAV antibody assay supporting gene therapy

BioAgilytix Labs has received FDA Breakthrough Device Designation for its anti-AAV antibody assay supporting Lexeo Therapeutics' gene therapy programme for Friedreich ataxia cardiomyopathy, a rare progressive disorder affecting approximately 15,000 people worldwide. The plate-based MSD anti-adeno-associated virus serotype rh.10 total antibody assay enables precise patient selection and monitoring for gene therapy programmes. The FDA's Breakthrough Device Designation expedites development and review of novel medical devices treating life-threatening or irreversibly debilitating conditions. BioAgilytix is among a limited number of contract research organisations to receive breakthrough designation for a diagnostic assay supporting an investigational device exemption. The Durham, North Carolina-based company operates laboratories across the US, Australia and Germany, providing bioanalytical testing services for pharmaceutical and biotechnology organisations.

Rapid Test Methods Ltd
Jun 18th, 2024
BBI and BioAgilytix Partner to Streamline and Simplify Bioanalytical Testing

BBI Solutions OEM Limited (BBI), a trusted expert provider of end-to-end solutions for the development of high-performance assays, has signed a partnership agreement with BioAgilytix, a leading global bioanalytical laboratory.

The Business Journals
Mar 26th, 2024
Durham firm cancels deal that promised 878 jobs

BioAgilytix in 2020 picked the Triangle over competing sites in Massachusetts for a $61.5 million expansion that was expected to add 878 local jobs.