Jobs in the United States

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Added 1 min ago
Loss Prevention Supervisor
SABRE INDUSTRIES INC.
Conroe, TX
Lead corrective action initiatives to address systemic process or control failures.
Added 2 mins ago
Quality Assurance/Quality Control Manager
LEIDOS, INC.
San Diego, CA
Leidos’ Undersea Systems Division is seeking an experienced Quality Assurance/Quality Control Manager in San Diego, CA to join a fast-paced Research & Development (R&D) engineering group…
Added 2 mins ago
Software Scrum Master (Agile SAFe)
Dynetics, Inc
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…and mission IT, large-scale intelligence systems, command and control, geospatial and data analytics, cybersecurity, logistics, training, and intelligence analysis and operations support.…
Added 2 mins ago
Cloud/SecDevOps Engineer
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…Agent (VDA) installation and optimization into the image build…
Added 4 mins ago
Civil/Site Engineer
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Lansing, MI · Grand Rapids, MI
Colliers Engineering & Design is seeking a Civil Engineer to join our Civil/Site team in Michigan! The Civil/Site Engineer will be a key member of the Civil/Site design team, working on a…
Added 4 mins ago
Sr. Equipment Safety Engineer
SpaceX
Bastrop, TX
The SpaceX Environmental Health and Safety team is seeking a senior equipment safety engineer to provide strategic technical oversight of machine and equipment safety across manufacturing…
Added 4 mins ago
Sr. Environmental Engineer, Wetlands & Regulatory Compliance
SpaceX
Starbase, TX · Brownsville, TX
We are seeking an experienced Environmental Engineer or Consultant with specialized expertise in wetlands delineation, regulatory permitting, and environmental compliance to join our team.…
Added 4 mins ago
Sr. Environmental Engineer, Wetlands & Regulatory Compliance
SpaceX
Pecan Island, LA · Brownsville, TX
We are seeking an experienced Environmental Engineer or Consultant with specialized expertise in wetlands delineation, regulatory permitting, and environmental compliance to join our team.…
Added 4 mins ago
Process Safety Engineer
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College Station, TX
The SpaceX Terafab Environmental Health & Safety team in College Station, Texas is seeking a highly driven engineer to establish process safety parameters across a variety of cutting-edge…
Added 6 mins ago
Senior Software Engineer, Database Automation Engineer
PNC
Pittsburgh, PA · Birmingham, AL · Denver, CO · Strongsville, OH · Dallas, TX
…contribute to the company’s success. As a Senior Database Automation Engineer within PNC's Technology organization, you will be based in Pittsburgh, PA, Dallas, TX, Birmingham, AL, Denver,…
Added 6 mins ago
Senior Software Engineer, Database Automation
PNC
Pittsburgh, PA · Birmingham, AL · Denver, CO · Strongsville, OH · Dallas, TX
…to contribute to the company’s success. As a Senior Software Engineer within PNC's Technology organization, you will be based in Pittsburgh, PA, Denver, CO, Dallas, TX, Strongsville, OH or…
Added 6 mins ago
Senior Software Engineer - Database Automation and Platform Engineering
PNC
Pittsburgh, PA · Birmingham, AL · Denver, CO · Strongsville, OH · Dallas, TX
…to contribute to the company’s success. As a Senior Software Engineer within PNC's Technology organization, you will be based in Pittsburgh, PA, Dallas, TX, Denver, CO, Birmingham, AL or…
Added 6 mins ago
Senior Network Engineer
Genentech, Inc.
United States
As a Senior Network Engineer, you are a highly skilled, technology-agnostic expert responsible for solving unusually complex IT problems with innovative solutions across the entire…
Added 13 mins ago
Engineer - III
Morongo Casino Resort & Spa
Cabazon, CA
The Engineer III performs advanced maintenance, troubleshooting, and repair work on complex systems throughout Morongo Casino Resort & Spa. This position is responsible for ensuring the…
Added 13 mins ago
Engineer - II
Morongo Casino Resort & Spa
Cabazon, CA
The Engineer II performs intermediate-level maintenance, troubleshooting, and repair work throughout Morongo Casino Resort & Spa. This position supports the safe and efficient operation of…
Added 13 mins ago
Engineer - I
Morongo Casino Resort & Spa
Cabazon, CA
The Engineer I is responsible for performing a variety of general maintenance and repair tasks throughout Morongo Casino Resort & Spa. This position assists in maintaining the…
Added 19 mins ago
Engineer I - Engineering, Validation
Catalent Pharma Solutions LLC
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 25 mins ago
DO
Senior Construction Engineer/Construction Support
Department of Transportation
CA
- $11,437 to $14,315 USD / month
…delivered applications to be considered for this position, the Job Control number (JC-535114), PARF# 03-27-0367 and title of the position (Senior Transportation Engineer, CalTrans) must be…
Added 25 mins ago
DO
Senior Transportation Electrical Engineer/Construction Support
Department of Transportation
CA
- $11,437 to $14,315 USD / month
…delivered applications to be considered for this position, the Job Control number (JC-535125), PARF# 03-27-0366 and title of the position (Senior Transportation Electrical Engineer…
Added 28 mins ago
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 30 mins ago
Water Resources Coordinator/EIT
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…water supplies and protecting lives and property through flood control, your work will directly support public health, environmental sustainability, and infrastructure resilience. We bring…
Added 30 mins ago
Application & Support Engineer, Optical
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The Optical Engineer provides technical expertise, primarily in Ansys optics simulation tools, to support PADT’s customers while also assisting PADT’s ANSYS sales team through strategic…
Added 35 mins ago
Cyber Security Systems Engineer / Contract to hire / Onsite / Carrollton, TX
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Carrolton, TX
Our client, a global radiation?safety and measurement company, is actively hiring a Cyber Security Systems Engineer to join their team in Carrollton, TX! This role will be fully onsite.
Added 35 mins ago
Process Control Engineer
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The Staff Engineer, Process Control, functions as an integral team member and leader in the Process Control Systems Support Group for Evadale Mill. Position reports to the Manager Process…
Added 35 mins ago
Supplier Quality Engineer- Component Introduction - Autonomous Mobility
AUMOVIO
New Braunfels, TX
Plan, initiate, implement and control the appropriate supplier quality assurance measures along the complete process chain in the make/market phase for all supplied goods and services

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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