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IT Systems Engineer
Icarus
El Segundo, CA
- $120,000 to $160,000 USD / year
As an IT Systems Engineer, you will own internal IT from the laptop on a new hire's desk to the systems that keep our factory connected. This is a hands-on individual contributor role with…
Added 1 min 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 1 min 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 1 min ago
PI
Senior Principal AI Research Engineer
Pfizer Inc
WA · CA · MA · CT · NY
- $139,100 to $231,900 USD / year
As a Senior Principal AI Research Engineer, you will build the machine learning systems that transform innovative models into secure, reliable, and scalable capabilities for scientists…
Added 1 min ago
PI
Senior AI Research Engineer
Pfizer Inc
WA · CA · MA · CT · NY
- $106,000 to $176,600 USD / year
As a Senior AI Research Engineer, you will build the machine learning systems that transform innovative models into secure, reliable, and scalable capabilities for scientists across Pfizer.
Added 3 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 3 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 3 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 3 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 4 mins ago
Product Design Engineer - iPhone
Apple
Cupertino, CA
We are looking to add a product design engineer to the team. Day to day job responsibilities include the design of tight tolerance components for prototype systems, development of test…
Added 4 mins ago
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Project Engineer, Commercial Construction
GPAC
Saint Louis, MO
- $75,000 to $85,000 USD / year
…commercial and institutional projects. They are adding a Project Engineer / Assistant Project Manager to their project…
Added 5 mins ago
Engineer in Training I
Enbridge Employee Services Inc
Remote, United States
As an Engineer in Training I, Operations Planning, you'll gain hands on experience supporting maintenance and capital projects across pipeline and facility assets while learning from…
Added 5 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 5 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 5 mins ago
Supplier Development Engineer
Quantum Space
Tulsa, OK · Broken Arrow, OK
We are seeking a skilled and motivated Supplier Development Engineer to support the Ranger spacecraft program by ensuring the technical capability, quality, and performance of suppliers…
Added 5 mins ago
Manufacturing Engineer (Welding)
Quantum Space
Tulsa, OK · Broken Arrow, OK
We are seeking a skilled and technically driven Manufacturing Engineer (Welding) to lead the development, qualification, and implementation of welding processes for our Ranger spacecraft…
Added 5 mins ago
Validation and Verification Engineer, Aviation Engineering
Skyryse
El Segundo, CA · Los Angeles, CA
VALIDATION & VERIFICATION ENGINEER, AVIATION ENGINEERING - EL SEGUNDO, CA
Added 6 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 6 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 6 mins ago
Field Quality Engineer
Johnson Electric North America, Inc.
Plymouth, MI
Join Our Team as a Field Quality Engineer at Johnson Electric!
Added 6 mins ago
Test Engineer
Stryker Employment Company, LLC
Redmond, WA
Join Stryker as a Test Engineer supporting the manufacturing of defibrillator products and accessories. In this role, you’ll develop and maintain automated test systems and software used in…
Added 9 mins ago
SA
2027 Summer Intern - Supplier Development Engineer - 6463
Shield AI
Dallas, TX
- $35 to $45 USD / hour
We are seeking a highly skilled and motivated Supplier Development Engineer to join Shield AI, focusing on machined parts. The ideal candidate will have a strong background in supplier…
Added 9 mins ago
WD
Lead Software Engineer
Walt Disney Attractions Technology LLC
Lake Buena Vista, FL
- $148,300 to $198,800 USD / year
The Lead Software Engineer will report to the Manager, Software Engineering.
Added 9 mins ago
TT
AI-Native Electrical Engineer
True Talent Solutions Partners
Detroit, MI
- $110,000 to $250,000 USD / year
Added 9 mins ago
TT
Founding Full-Stack Engineer
True Talent Solutions Partners
San Francisco, CA
- $180,000 to $240,000 USD / year

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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