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Added 2 mins ago
Principal Design Verification Engineer , Annapurna Labs
Annapurna Labs (U.S.) Inc.
Cupertino, CA
…and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or…
Added 7 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 11 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 11 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 11 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…
Added 11 mins ago
Senior Automated Test Systems Engineer (Onsite)
RTX
United States
Design and develop automated test systems, including test hardware and software, to support product engineering and manufacturing.
Added 11 mins ago
Software Engineer (Embedded)
RTX
United States
Collins Aerospace is seeking a qualified Software Engineer to support the Identification Friend or Foe (IFF) programs onsite in Marlborough, MA
Added 11 mins ago
Software Engineer II
RTX
United States
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,…
Added 11 mins ago
Senior Software Engineer (Embedded SW)
RTX
United States
Collins Aerospace is seeking a qualified Sr Software Engineer to support the Identification Friend or Foe (IFF) programs onsite in Marlborough, MA
Added 12 mins ago
Engineer II, Manufacturing
Careers | ElDorado National California Inc
Riverside, CA
…closely with manufacturing, quality, and engineering teams to support new product launches and continuous improvement initiatives. Assignments are moderately complex and require technical…
Added 12 mins ago
A
Sr. Lead Application Developer
ADP
Roseland, NJ
- $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 13 mins ago
DevSecOps Security Engineer
Leidos
Egg Harbor Township, NJ
Partner with platform and application teams to triage vulnerabilities, remediate findings, and support security incident response and root cause analysis .
Added 13 mins ago
ER
Senior Network Engineer II
EVEREST REINSURANCE COMPANY
Warren, NJ
- $119,000 to $140,000 USD / year
Engineer and support Zscaler (ZIA, ZPA, ZDX), Palo Alto firewalls (Panorama, VM-Series), and Zero Trust / network segmentation.
Added 13 mins ago
Software Engineer
Ana-Data Consulting Inc
Hoboken, NJ
…& performance requirements. Provide training and technical support to end users. Experience must include utilizing: .NET Framework, C#, ASP.NET, MVC, Typescript, Entity Framework, Azure,…
Added 13 mins ago
C
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…
Added 13 mins ago
Data Engineer, Clinical Operations
Bristol Myers Squibb
Princeton, NJ
As a Data Engineer , you will play a vital role in supporting the broader Data Engineering community to deliver cutting-edge data and analytics platforms for our Global Drug Development…
Added 13 mins ago
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Senior Back End Engineer
TEKsystems
Jersey City, NJ
- $70 to $85 USD / hour
by 2028. MCC-Field is the next-generation field application, serving site operations, third-party contractors, and preventive maintenance teams across
Added 14 mins ago
AT
Information Security Solutions Engineer II
Auto Truck Group LLC
Trenton, NJ
- $105,050 to $149,700 USD / year
Holman is looking for a Security Engineer to work where cloud infrastructure and software development meet. You will review and design security architecture for our cloud environments,…
Added 14 mins ago
Advanced Sciences and Technologies (AS&T)- Computer Scientist - Level 4/5 (Pomona, NJ)
AS&T
Pomona, NJ
Advanced Sciences and Technologies (AS&T)- Computer Scientist - Level 4/5 (Pomona, NJ)Skip to application form
Added 14 mins ago
EG
Staff AI & Data Engineer – Databricks
Eliassen Group
Trenton, NJ
- $80 to $90 USD / hour
Our client is seeking a highly experienced Staff AI & Data Engineer to design and build enterprise-grade data and AI solutions on Databricks. This hands-on role focuses on strengthening the…
Added 14 mins ago
EG
QA Automation Engineer
Eliassen Group
Trenton, NJ
- $75 to $82 USD / hour
Experience as an Automation Engineer using tools such as Selenium with Java or similar.
Added 15 mins ago
Product Regulatory Affairs Engineer II
Detroit Diesel Corporation
Detroit, MI
As a Product Regulatory Affairs Engineer II, you will support emissions compliance and certification activities for on-highway and non-road products throughout their lifecycle. This role…
Added 18 mins ago
G
Fire Protection Design Engineer
GPAC
Charlotte, NC
- $105,000 to $130,000 USD / year
A firm I am partnered with is seeking a highly motivated Senior Fire Protection design Engineer with expertise in fire hazards analysis, and fire protection system design. You will…
Added 20 mins ago
G
Fire Protection Design Engineer
GPAC
Culver City, CA
- $105,000 to $130,000 USD / year
A firm I am partnered with is seeking a highly motivated Senior Fire Protection design Engineer with expertise in fire hazards analysis, and fire protection system design. You will…
Added 20 mins ago
G
Fire Protection Design Engineer
GPAC
West Hollywood, CA
- $105,000 to $130,000 USD / year
A firm I am partnered with is seeking a highly motivated Senior Fire Protection design Engineer with expertise in fire hazards analysis, and fire protection system design. You will…

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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