Batch Records Support Jobs

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5d ago

Senior Associate - Biomanufacturing, Compliance - Manufacturing Technical Support

Catalent Madison, WI

Madison, WI

5d ago

Full time Advanced Manufacturing Batch Records Biotech Pharma

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Job Description

Senior Associate in Biomanufacturing Compliance and Manufacturing Technical Support at Catalent, onsite in Madison, WI, delivering end-to-end technical support in a cGMP environment with emphasis on incident response, tech transfer, and continuous improvement.

Responsibilities

Serve as incident commander during rapid response, delivering real-time troubleshooting and technical guidance for manufacturing operations.
Collaborate with clients and cross-functional teams across Process Development, Manufacturing, QA/QC, Supply Chain, Project Management, and Facilities to enable tech transfer, monitor process performance, and drive project delivery.
Author and oversee batch documentation, ensuring GMP-compliant execution and providing strategic manufacturing support.
Analyze process data, present project updates, identify trends, and generate internal and client-facing reports.
Identify optimization opportunities for processes and equipment, and support business case development for improvements.
Support deviations, change controls, and CAPAs, including root cause analysis, impact assessments, and implementation of corrective actions.
Act as a technical subject matter expert, coaching teammates and expanding overall team capability.
Partner with engineers and scientists to ensure facility readiness, enable process transfer, and sustain operational excellence.
Contribute to site and network initiatives as needed.
Other duties as assigned.

Requirements

Minimum education: Associate degree in STEM with 6+ years of related experience; a Bachelor’s with 3+ years or a Master’s with at least 1 year of related experience is preferred.
Strong technical writing and documentation skills, including authoring and revising SOPs, batch records, and reports.
Experience applying statistical methods for data analysis, trending, and reporting to support process performance.
Hands-on experience operating and troubleshooting manufacturing equipment, including single-use systems and consumables.
Understanding of tech transfer, facility fit, and process scale-up, with experience supporting late-phase, PPQ, or commercial programs preferred.
Broad bioprocess knowledge across upstream (cell culture), downstream (purification), and/or molecular therapeutics (e.g., mRNA) in cGMP environments.
Physical requirements: ability to see, hear, read, and write clear English; frequent sitting, standing, walking, reading documents, and using a computer; occasional stooping, kneeling, crouching, bending, carrying or grasping; frequent lifting up to 10 pounds and occasional up to 50 pounds; must comply with EHS responsibilities.

Technologies

Single-use systems

Benefits

Defined career path and annual performance reviews
Diverse, inclusive culture
Potential for career growth on an expanding team dedicated to preserving and improving lives
152 hours of PTO plus 8 paid holidays
Generous 401K matching
Medical, dental, and vision benefits
Tuition reimbursement

Position Details

Work Schedule: Alternating 3/4-4/3 weekly schedule with core hours 11:00 PM – 10:00 AM
Location: On-site in Madison, WI
On-call rotation required and compensated

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