Jobs in the United States

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Added 2 mins ago
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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 3 mins ago
Engineer I - Engineering, Validation
Catalent
Madison, WI
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…
Added 6 mins ago
AI Engineer 4 (AI Foundations: World Model, RL, Causal Inference, Sequential Data)
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McLean, VA · Cambridge, MA · San Jose, CA · NY
Lead cross-functional technical reviews for new AI system deployments, ensuring security, data governance, and compliance standards are met
Added 6 mins ago
LTAMDS Production Execution Chief Engineer (Onsite)
RTX
United States
Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Added 6 mins ago
LTAMDS Development Execution Chief Engineer (Onsite)
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Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Added 6 mins ago
Electronic Test Technician - 1st Shift (Onsite)
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…test, & to perform other tasks as defined by the Senior Test Engineer or the Test Department…
Added 6 mins ago
Senior Automated Test Systems Engineer (Onsite)
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The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Added 6 mins ago
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The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Added 6 mins ago
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The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Added 6 mins ago
Senior Software Engineer (Embedded SW)
RTX
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The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Added 7 mins ago
K
Sr.Structural Engineer-Kiewit Nuclear Solutions-Lenexa, KS, Houston, TX, & Oak Ridge, TN, Itasca, IL
Kiewit
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- $164,000 to $172,000 USD / year
…to Department of Energy science, environmental and nuclear security mission capabilities. With these broad capabilities, we operate in the power utility, renewable energy, industrial, and…
Added 7 mins ago
Principal Consultant - Databricks
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…decisions align with customer outcomes, operational requirements, security, performance, reliability, and cost goals. This is a remote U.S.-based role working primarily in the Eastern Time…
Added 7 mins ago
VN
Water/Wastewater Senior Project Engineer
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- $125,000 to $135,000 USD / year
Compliance & Standards : Ensure all project designs adhere to corporate Technical, Environmental, and Health & Safety/Security standards.
Added 7 mins ago
PT
Facilities Project Engineer
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- $50 to $60 USD / hour
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Added 7 mins ago
DevSecOps Security Engineer
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Added 7 mins ago
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Senior Network Engineer II
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Join our Global Network Engineering & Operations team to design, implement, and support enterprise network and security solutions across global data centers, Azure cloud environments, and…
Added 7 mins ago
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Cloud Security Engineer
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- $50 to $55 USD / hour
Our client is seeking a Cloud Security Engineer to join their team. As a Cloud Security Engineer, you will be part of the Security Engineering organization supporting cloud security…
Added 8 mins ago
Software Engineer - AI & Agentic Systems
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We are seeking a Software Engineer to help our team design, build, and operate practical AI tools that improve how people find information, automate tasks, and integrate AI into their daily…
Added 8 mins ago
Software Quality Engineer I
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Added 8 mins ago
AD
Sr. Network Engineer
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- $143,572.41 to $149,040 USD / year
…and safeguard company resources via developing and testing security protocols. Deploy new networks (LAN, WLAN, WAN) and assist Global AMD Network Engineering/Architecture team with…
Added 8 mins ago
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Infrastructure Engineer III
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…such as routing, switching, wireless connectivity, and network…
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Forward Deployed Engineer
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Catalent Pharma Solutions LLC

Engineer I - Engineering, Validation

Madison, WI, United States

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Job details

Apply by: Nov 30, 2026
Posting language: English
Posted: Nov 6, 2026

Original job description

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.

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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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