Senior Quality Engineer

The Jackson Laboratory; Farmington (CT); Hybrid; USD 80,000 - 116,000; Full time

Job summary

The Jackson Laboratory is hiring a Senior Quality Engineer to oversee quality throughout the product lifecycle. You will apply QbD, QRM, and statistical methods to strengthen product quality, data integrity, and regulatory compliance. The role partners with Operations, R&D, and Global Quality to drive CAPA and continuous improvement.

Hybrid role in Farmington, CT with 2–3 days onsite. Requires 5+ years in quality engineering within regulated biotech or life sciences settings; a bachelor's in a

Qualifications

• Experience leading quality engineering programs in regulated environments.
• Strong knowledge of GMP, GDP, and data integrity principles.
• Familiarity with QMS, CAPA, change control, and audits.

Responsibilities

• Provide quality oversight across product lifecycle and manufacturing operations.
• Review batch records, release documentation, and change controls.
• Lead quality investigations and root cause analyses (5 Why, Fishbone).
• Apply QbD, QRM, SPC, and DOE to improve process capability.
• Support internal and supplier audits, and inspection readiness.

Skills

Quality Engineering

cGMP

QbD

QRM

CAPA

Statistical analysis

SPC

DOE

Data integrity

Risk management

Cross-functional leadership

Regulatory audits

Education

Bachelor's degree in a technical discipline

Master’s degree (a plus)

Tools

IQ/OQ/PQ

QMS

Job description

About the Role

The Jackson Laboratory is seeking a Senior Quality Engineer to provide technical quality oversight throughout the product lifecycle, ensuring our products consistently meet customer and internal quality requirements. In this role, you will help develop and advance Quality Engineering practices across laboratory operations through batch record review and release, product disposition, documentation oversight, process validation, quality investigations, risk management, and continuous improvement initiatives. Partnering closely with Operations, Research & Development, Global Quality, and cross‑functional teams, you will apply statistical analysis, Quality by Design (QbD) principles, Quality Risk Management (QRM), and data‑driven decision‑making to strengthen product quality, process robustness, data integrity, and regulatory compliance.

Location: Farmington, CT (Hybrid) 2-3 days per week onsite Salary Range: $80,167 - $116,242 based on years of related experience and internal equity considerations

What You’ll Contribute

• Establish and mature Quality Engineering practices, standards, and processes that support product quality, regulatory compliance, and operational excellence across laboratory and manufacturing operations.
• Review, approve, and release batch records, manufacturing documentation, and quality records to support product disposition and ensure compliance with quality requirements.
• Provide technical quality oversight throughout the product lifecycle, including development, technology transfer, manufacturing, product release, change management, and continued process verification.
• Apply regulatory requirements and industry standards, including cGMP, FDA 21 CFR Parts 210, 211, and 11, and ICH guidelines (Q8, Q9, Q10).
• Support and lead qualification and validation activities, including equipment qualification (IQ/OQ/PQ), process validation, analytical method qualification/validation, and validation lifecycle management.
• Apply QbD, QRM, and statistical methodologies to improve process capability, product quality, and operational performance.
• Lead quality investigations using structured root cause analysis methodologies (e.g., 5 Why, Fishbone) and drive effective CAPA implementation, effectiveness verification, and continuous improvement.
• Review, approve, and provide quality oversight for change controls, deviations, specifications, procedures, protocols, and other controlled documents within the Quality Management System (QMS).
• Lead and facilitate risk assessments using tools such as FMEA, Hazard Analysis, and Risk Ranking to support product disposition, process changes, validation activities, and business decisions.
• Apply statistical analysis, including Statistical Process Control (SPC), process trending, and hypothesis testing, to identify improvement opportunities and support data‑driven decisions.
• Support internal audits, supplier audits, and inspection readiness activities.
• Partner with Operations, R&D, Quality Control, and cross‑functional teams to resolve quality issues, strengthen quality culture, standardize processes, and facilitate knowledge transfer.

What You Bring

• Bachelor's degree in Engineering, Biology, Chemistry, Microbiology, Biotechnology, Biomedical Engineering, Chemical Engineering, Quality Engineering, Life Sciences, or a related technical discipline (a combination of education and experience may be considered). Master’s degree would be a plus.
• 5+ years (8+ preferred) of progressive experience in Quality Engineering, Quality Assurance, Manufacturing Quality, or Product Quality within a regulated biotechnology, pharmaceutical, medical device, or life sciences environment.
• Demonstrated experience developing, implementing, and maturing Quality Engineering programs, processes, standards, and best practices in a regulated environment.
• Experience providing quality oversight for GMP-regulated manufacturing or laboratory operations, including batch record review and release, product disposition, investigations, change control, process validation, and quality risk management.
• Strong understanding of Quality Management Systems (QMS), Good Documentation Practices (GDP), ALCOA+ data integrity principles, cGMP, GLP, and applicable regulatory standards (e.g., FDA, ICH, ISO).
• Experience supporting qualification and validation activities, including IQ/OQ/PQ, process validation, and analytical method qualification/validation.
• Demonstrated ability to apply QbD, QRM, FMEA, and risk‑based decision‑making to improve product quality and process robustness.
• Proficiency in statistical analysis and data‑driven quality methodologies, including SPC, process capability analysis, hypothesis testing, trending, and Design of Experiments (DOE).
• Proven experience leading cross‑functional quality initiatives, influencing stakeholders without direct authority, and driving continuous improvement through Lean, Six Sigma, and quality system tools.
• Experience developing quality metrics, monitoring KPIs, and analyzing trends to identify opportunities for improvement.
• Experience supporting internal and external audits, supplier quality activities, regulatory inspections, deviation investigations, CAPA, and inspection readiness.
• Strong technical writing, communication, and leadership skills, with the ability to mentor others, manage multiple priorities, and build a culture of quality excellence.
• Ability to travel up to 20%.

Physical Demands

Primarily sedentary; sitting most of the time with brief periods of standing or walking; occasional lifting up to 10 lbs.

About JAX

The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute‑designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California, New York, Florida), Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health. Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org.

EEO Statement

The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non‑discrimination laws.

Bar Harbor

The Jackson Laboratory's 43-acre scenic Bar Harbor campus is nestled between the Gulf of Maine and the mountains of Acadia National Park. Some of the best hiking and biking in the world (over 50 square miles of mountains, lakes, views, and dramatic coastline) is accessible from our campus. We are one mile from downtown Bar Harbor, which offers a vibrant downtown district with a plethora of restaurants, shops, museums, and galleries.

Ellsworth

The Charles E. Hewett Center in Ellsworth, Maine, is a state‑of‑the‑art facility that serves researchers world wide. The facility represents the culmination of nine decades of unmatched experience and leadership in breeding and caring for laboratory mice. Ellsworth, Maine, is one of Maine's fastest growing cities. With a growth rate of nearly 20%, Ellsworth is a bustling year‑round community and acts as a hub for surrounding towns. It is located nearby Acadia National Park and hosts numerous special events, concerts and festivals each year. Residents have access to fabulous shopping, recreation, museums, galleries, and dining at a variety of independent restaurants.

Farmington

JAX Genomic Medicine is transforming medicine by improving patient care, lowering costs, and increasing life span and health span. JAX Genomic Medicine's research focuses on the complex genetic causes of disease and on the development of genomic solutions tailored to each person's unique genetic makeup. JAX Genomic Medicine sits on a 17-acre site on the campus of the University of Connecticut Health Center. The 183,500-square-foot facility opened in the fall of 2014. Now, it houses over 300 biomedical researchers, technicians, and support staff in state‑of‑the‑art computing facilities and laboratories. In Connecticut, JAX resides in the scenic town of Farmington, in the state’s capitol region. The Hartford region, which offers some of the best public schools in the country, is made up of both bigger cities and smaller, charming historic New England towns. JAX Genomic Medicine is also geographically located within 2 hours of Boston and New York and is close to multiple transportation systems, including bus lines, highways, railroads and international airports.

Sacramento

The JAX Mice, Clinical and Research Services facility is located in Sacramento, the state capital of California. Sacramento is less than a two‑hour drive from San Francisco, Napa Valley, and scenic Lake Tahoe, and a short flight to both Los Angeles and Orange County. Sacramento is the birthplace of the nation’s Farm to Fork movement, and offers excellent restaurants, gastro‑pubs, wineries, theaters, and museums. Outdoor activities are plentiful: Boating, white water rafting, and riding the scenic bicycle trails are popular. Housing and other costs of living are more affordable in Sacramento and its surrounding suburbs than in most other neighboring areas in the North Bay, making Sacramento one of the hottest housing markets in the country year after year.

Augusta

JAX's Maine Cancer Genomics Initiative (MCGI) is located in Augusta, Maine, in the Harold Alfond Center for Cancer Care (HACCC), at Maine General Hospital. It began operations in 2016 with three overarching goals: to provide cancer genomic testing for Maine cancer patients; to develop and deliver physician education about clinical genomic cancer diagnostics; and to build a network in Maine of oncology practices conducting studies in genomic medicine.