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SMT Process Engineer
Actalent
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Job Title: Process EngineerJob DescriptionThe Process Engineer supports and improves manufacturing processes within an electronics production environment. This role focuses on developing…
Added just now
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Actalent
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- $50 USD / hour
Job Title: Test EngineerJob DescriptionWe are seeking an experienced Test Engineer to join a growing engineering team focused on power electronics products. In this role, you will design,…
Added 4 mins ago
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…confidence in Samsung Austin Semiconductor and supporting the development of yield learning models using wafer sort or final test data to identify root causes and establish…
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Quality Systems Engineer
x Varian Medical Systems, Inc.
United States
Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Engineer to join our Quality organization in Palo Alto, California. In this role, you will support the…
Added 6 mins ago
Senior Software Engineer
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Application Development: Experience with graphical application frameworks such as Qt and software integration with hardware or embedded systems.
Added 8 mins ago
Summer 2027 Provider Delivery Software Engineer enGen Undergraduate Intern
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The Summer 2027 Provider Delivery Software Engineer Undergraduate Internship provides students with an opportunity to gain practical, hands-on experience developing enterprise-scale…
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Senior Principal AI Research Engineer
Pfizer Inc
WA · CA · MA · CT · NY
- $139,100 to $231,900 USD / year
The systems you build will support researchers tackling some of the toughest challenges in medicine, helping accelerate insights across discovery, development, and translational science.
Added 8 mins ago
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Senior AI Research Engineer
Pfizer Inc
WA · CA · MA · CT · NY
- $106,000 to $176,600 USD / year
The systems you build will support researchers tackling some of the toughest challenges in medicine, helping accelerate insights across discovery, development, and translational science.
Added 10 mins ago
Principal Design Verification Engineer , Annapurna Labs
Annapurna Labs (U.S.) Inc.
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…You’ll be part of a team that drives innovation in custom chip development, directly impacting the future of cloud…
Added 11 mins ago
Product Design Engineer - iPhone
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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 16 mins ago
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Lead Software Engineer
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- $148,300 to $198,800 USD / year
The Lead Software Engineer will report to the Manager, Software Engineering.
Added 19 mins ago
Director, Full-Stack Engineer - AML (Anti Money Laundering)
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NY · McLean, VA · Cambridge, MA
Expertise in the strategic application of agentic AI coding tools to solve systemic development challenges
Added 20 mins ago
LTAMDS Production Execution Chief Engineer (Onsite)
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Added 20 mins ago
LTAMDS Development Execution Chief Engineer (Onsite)
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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…
Added 20 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 20 mins ago
Senior Automated Test Systems Engineer (Onsite)
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…businesses, world-class operations and investments in research and development, we offer capabilities and opportunity no one else can. Together, we push the boundaries of known science and…
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Experience in C++ software application development
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Software Engineer II
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Collins Aerospace is seeking a qualified Senior Software Engineer to support the Identification Friend or Foe (IFF) programsAt RTX, the world's largest aerospace and defense company,…
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Senior Software Engineer (Embedded SW)
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Experience in C++ software application development in Real Time Embedded Systems
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Engineer II, Manufacturing
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Responsible for the design, development, and implementation of tooling solutions for large-scale assembly operations, including metal cutting, machining, and welding. This position focuses…
Added 21 mins ago
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Sr. Lead Application Developer
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- $107,400 to $264,300 USD / year
ADP Innovation Labs is looking for a Sr. Lead Software Engineer with extensive NodeJS experience to join an emerging team.
Added 21 mins ago
DevSecOps Security Engineer
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Leidos is seeking a DevSecOps Security Engineer to join the Air Traffic Business Area within the Homeland Sector, supporting the development of the Leidos Common Automation Platform…
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Software Engineer - AI & Agentic Systems
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The application window is expected to close on: 12/20/2026.
Added 21 mins ago
Associate Specialist, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite)
Merck
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…multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile formulations,…
Added 22 mins ago
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Software Development Engineer in Test.
Cognizant
Princeton, NJ
- $96,000 to $112,500 USD / year
As a Software Development Engineer in Test (SDET) – Automation Architect, you will design and deliver advanced automated quality validation for Azure AI and generative AI solutions. You…

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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