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Quality Control Inspector II (1st Shift)
Medline Industries, LP
MFG- Neptune, NJ
- $23.25 to $33.75 USD / hour
…results, providing product disposition, ensuring inventory control, performing final inspections, and ensuring compliance with quality procedures and company…
Added 2 mins ago
SS
Kitchen Prep Cook & Food Reclamation Driver
Society St. Vincent De Paul Alameda
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- $23.83 to $24.54 USD / hour
…partner agencies, grocery stores, and restaurants to support meal production and minimize…
Added 3 mins ago
Loss Prevention Supervisor
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Establish and standardize inventory control procedures across all sites, including cycle counts, audits, and variance resolution processes.
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AI Products & Transformation Manager
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…scientists, analytics teams, platform owners, governance, risk, and control partners to deliver production-ready…
Added 4 mins ago
NB
Froster
Nothing Bundt Cakes #152
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- $9.5 to $10 USD / hour
…for our guests and contributes to superior service by meeting production demands. Following a strict proprietary recipe, NbC cake-frosting methods and food safety standards, the Froster…
Added 4 mins ago
Senior Amazon Connect System Administrator – DoD Healthcare
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Remote, United States
Experience supporting enterprise production applications in a structured incident and change management environment.
Added 4 mins ago
Salesforce Health Cloud Developer – DoD Healthcare
LEIDOS, INC.
Remote, United States
Perform root cause analysis and implement corrective actions for recurring software defects and production incidents.
Added 4 mins ago
Quality Assurance/Quality Control Manager
LEIDOS, INC.
San Diego, CA
Bridge R&D to Production: Design and implement scalable quality checkpoints and control gates that support the transition from exploratory R&D prototypes to disciplined, repeatable low…
Added 4 mins ago
Cloud/SecDevOps Engineer
LEIDOS, INC.
Clarksburg, WV
Troubleshooting: Identify and fix issues in production, and monitor system performance
Added 5 mins ago
A
Manufacturing Technician I, MD Fill - B2 Shift
AbbVie
Waco, TX
- $18.6 to $24.5 USD / hour
Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as…
Added 6 mins ago
LMS Coordinator
General Motors LLC
Arlington, TX
Support achievement of production schedules & product requirements by applying lean manufacturing principles with a focus on variation reduction, control costs, and achieve productivity…
Added 7 mins ago
Assistant Director - Learning Design Enablement
NU USA Northeastern University
Boston, MA
This role owns the quality control process for Learning Design Enablement. It sets the standards the team designs against and confirms products meet that standard before handoff to Learning…
Added 7 mins ago
Senior Software Engineer, Database Automation Engineer
PNC
Pittsburgh, PA · Birmingham, AL · Denver, CO · Strongsville, OH · Dallas, TX
Develop integrations with enterprise tools, APIs, source control systems, and CI/CD pipelines.
Added 7 mins ago
Senior Software Engineer - Database Automation and Platform Engineering
PNC
Pittsburgh, PA · Birmingham, AL · Denver, CO · Strongsville, OH · Dallas, TX
Experience working with REST APIs and source control platforms such as Git.
Added 8 mins ago
Raw Material Planner (coatings/chemicals)
Hempel (USA), Inc.
Remote, United States
Ensure efficient and cost-effective raw materials purchasing and inventory control.
Added 9 mins ago
Program Manager, Maintenance
Anduril Industries
Ashville, OH
…turns thousands of data streams into a realtime, 3D command and control center. As the world enters an era of strategic competition, Anduril is committed to bringing cutting-edge autonomy,…
Added 10 mins ago
Senior Design Engineer - Audiovisual (AV)
Avidex Industries LLC
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Experience with production control rooms, flypacks, and temporary production environments
Added 17 mins ago
Manufacturing Digital Enablement Leader - ODL - Northeast US
EKC Advanced Electronics USA, LLC
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· Coordinate updates, lifecycle activities, technical debt reduction, and operational readiness with minimal production disruption.
Added 17 mins ago
Lead Machinist
Quantum Space
Tulsa, OK · Broken Arrow, OK
…and take ownership of shop scheduling, quality, safety, and production…
Added 17 mins ago
Lead Machinist
Quantum Space
Hawthorne, CA
…and take ownership of shop scheduling, quality, safety, and production…
Added 18 mins ago
Material Handler
GE Precision Healthcare LLC
United States
Knowledge and understanding of production process, work instructions, documentation configuration control, non-conforming & rework documentation requirements and operates within them to…
Added 18 mins ago
CT
Building Assembler 1
Crown Technical Systems, Llc
CA
- $18.59 to $25.1 USD / hour
…concentrating on sophisticated, state-of-the-art relay and control panels, medium voltage switchgear, and enclosures (power/control buildings/ E-Houses). We specialize in customized,…
Added 19 mins ago
Manager, Governance & Program Execution
FMR LLC
Covington, KY
…and maintaining policies and procedures, supporting quality control and training programs, advancing data analytics and reporting capabilities, and coordinating cross-functional initiatives…
Added 19 mins ago
Executive Chef
Palm Desert, CA
…We are seeking a Executive Chef to execute food preparation, production, and control of labor and food costs throughout all food outlets and banquet operations to meet the hotel’s high…
Added 21 mins ago
Engineer I - Engineering, Validation
Catalent Pharma Solutions LLC
Madison, WI
…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…

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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