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Quality Engineer
GPAC
Danbury, CT
- $85,000 to $125,000 USD / year
Added just now
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Quality Engineer
GPAC
Bristol, CT
- $85,000 to $125,000 USD / year
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Quality Engineer
GPAC
New Haven, CT
- $85,000 to $125,000 USD / year
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Quality Engineer
GPAC
Middletown, CT
- $85,000 to $125,000 USD / year
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Quality Engineer
GPAC
Hartford, CT
- $85,000 to $125,000 USD / year
Added 1 min ago
Principal Systems Engineer - P5
Boston Scientific
Maple Grove
Boston Scientific is seeking a highly motivated and experienced Principal Systems Engineer - P5 to provide technical leadership in the development of complex medical device systems within…
Added 3 mins ago
Forward Deployed Solution Engineer – Applied AI FDE
ServiceNow
Remote, United States
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…
Added 3 mins ago
Summer 2027 Provider Delivery Software Engineer enGen Undergraduate Intern
Highmark Health
Jefferson City, MO
The Summer 2027 Provider Delivery Software Engineer Undergraduate Internship provides students with an opportunity to gain practical, hands-on experience developing enterprise-scale…
Added 6 mins ago
Principal Design Verification Engineer , Annapurna Labs
Annapurna Labs (U.S.) Inc.
Cupertino, CA
We are looking for a passionate Principal Design Verification Engineer to join our newly formed team responsible for verifying high-speed I/O and scale-up/out components across the SoC. You…
Added 6 mins ago
Engineering Manager
Fortive
Remote, United States
ServiceChannel is looking for an experienced software engineer and technical leader to help guide a globally distributed team building and evolving our SaaS platform.
Added 6 mins ago
Engineering Manager
Fortive
Remote, United States
ServiceChannel is looking for an experienced Software Engineer and technical leader to help guide a globally distributed team building and evolving our SaaS platform.
Added 6 mins ago
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Mechanical Project Engineer
GPAC
Kansas City, KS
- $75,000 to $105,000 USD / year
The Project Engineer works directly with Project Managers to keep mechanical projects organized, documented, and moving from buyout through closeout. You will split your time between the…
Added 7 mins ago
Full Stack Engineer
Infisical
Remote, United States
We’re looking for an exceptional Full Stack Engineer to help us build, optimize, and expand the foundation of the platform.
Added 7 mins ago
Senior Full Stack Engineer
Infisical
Remote, United States
We’re looking for an exceptional Senior Full Stack Engineer to help us build, optimize, and expand the foundation of the platform.
Added 8 mins ago
Applied AI Engineer Intern
Parspec
San Mateo, CA
We’re seeking an Applied AI Engineer Intern to join Parspec. This role is part of the AI team and works closely with Product and Engineering on fast-moving, real-world applications of AI.
Added 8 mins ago
Embedded Software Engineer
CFO Trane U.S. Inc.-CFO
Clarksville, TN · La Crosse, WI
…driving analytics for greater efficiency, your ideas will help engineer solutions for stronger communities and a sustainable…
Added 8 mins ago
Field Quality Engineer
Johnson Electric North America, Inc.
Plymouth, MI
As our next Field Quality Engineer, you’ll manage customer nonconformance issues for imported products throughout the Americas. Your expertise in customer quality, 8D problem-solving,…
Added 12 mins ago
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AI-Native Electrical Engineer
True Talent Solutions Partners
Detroit, MI
- $110,000 to $250,000 USD / year
- Develop prototype hardware into structured, testable, customer-ready alpha systems.
Added 12 mins ago
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Founding Full-Stack Engineer
True Talent Solutions Partners
San Francisco, CA
- $180,000 to $240,000 USD / year
Added 12 mins ago
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Senior Forward Deployed Engineer, Operate
True Talent Solutions Partners
New York, NY
- $170,000 to $205,000 USD / year
- Five to 15 years of software engineering experience building and deploying customer-facing production systems end to end.
Added 15 mins ago
AI Engineer 4 (AI Foundations: World Model, RL, Causal Inference, Sequential Data)
Capital One
McLean, VA · Cambridge, MA · San Jose, CA · NY
…in using machine learning to create real-time, personalized customer experiences. Our investments in technology infrastructure and world-class talent - along with our deep experience in…
Added 15 mins ago
AI Engineer 5 (AI Foundations: Evaluations and Agentic Workflows)
Capital One
McLean, VA · San Francisco, CA · Cambridge, MA · San Jose, CA · NY
…in using machine learning to create real-time, personalized customer experiences. Our investments in technology infrastructure and world-class talent - along with our deep experience in…
Added 15 mins ago
Director, Full-Stack Engineer - AML (Anti Money Laundering)
Capital One
NY · McLean, VA · Cambridge, MA
As a Director, Full-stack Engineer at Capital One, you will lead high-performing engineering teams working to define the future of banking in the cloud. You will partner closely with…
Added 15 mins ago
LTAMDS Production Execution Chief Engineer (Onsite)
RTX
United States
The LADS SBU is seeking an Execution Production Chief Engineer (P5) to support technical execution for the LTAMDS (Lower Tier Air and Missile Defense Sensor) Production program. LTAMDS is a…
Added 15 mins ago
LTAMDS Development Execution Chief Engineer (Onsite)
RTX
United States
The LADS SBU is seeking an Development Execution Chief Engineer (P5) to support technical execution for the LTAMDS (Lower Tier Air and Missile Defense Sensor) Development program. LTAMDS is…

Closed listing

Catalent

Engineer I - Engineering, Validation

Madison, WI, United States

This opening has closed.

The original listing is kept below for reference.

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Job details

Posting language: English
Posted: Nov 6, 2026

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Original job description

Archived listing. The details below describe a past opening.

About Site Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.

Position Summary We have an opportunity for an Engineer I - Engineering, Validation to join our team in Madison, WI. This role supports quality assurance and validation activities to ensure compliance with regulatory and internal quality standards. The position involves oversight of validation programs, commissioning and qualification of equipment, and collaboration with cross‑functional teams to maintain high standards of quality and compliance. The successful candidate will contribute to continuous improvement and support the manufacture and release of high‑quality drug substances.

Shift: M-F 8am-5pm Location: Madison, WI 100% Onsite

The Role

Review and approve validation documents
Support commissioning and qualification of equipment and utilities
Lead validation activities for new equipment and systems
Serve as QA subject matter expert for Validation and Risk Management
Assess change controls for impact to validated systems
Support audits and regulatory inspections
Investigate deviations related to validation activities
Maintain Validation Master Plan
Partner with Manufacturing, Process Development, Facilities, Regulatory Affairs, and Quality teams
Manage validation contractors when necessary
Provide training and technical support

The Candidate Minimum Requirements

Bachelor's degree in a technical field (Biology, Biotechnology, Engineering, or related) with 7+ years of relevant experience OR Master's degree in a technical field with 4+ years of relevant experience
Strong knowledge of cGMP regulations
Knowledge of validation standards including ISPE and ASTM
Experience with validation and qualification of complex equipment and systems
Experience drafting, reviewing, executing, and approving validation protocols and reports
Experience supporting validation activities in a regulated pharmaceutical or biotech environment
Experience with change controls, deviations, CAPAs, investigations, and risk assessments

Preferred Skills & Background

Biopharmaceutical, biotech, or pharmaceutical manufacturing experience
Experience with aseptic processing
Experience with cell culture
Experience with protein purification
Process validation experience
21 CFR Part 11 compliance experience
Validation of computerized systems
Continuous improvement and quality systems enhancement
Quality Risk Management expertise

Why You Should Join Catalent

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Competitive paid time off + 8 paid holidays
Community engagement and green initiatives
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond - it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

About employer

More about this job

Skills

Quality assurance
Regulatory compliance
Collaboration
Process improvement
Risk management
Inspection
Regulatory affairs
Provide training
Technical support
Biotechnology
Pharmaceutical processes
Quality control systems
Community engagement

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