Lead - Biomanufacturing Compliance - Investigator, Deviations

Catalent; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

8 paid holidays

Job summary

Catalent’s Madison, Wisconsin site seeks a Lead - Biomanufacturing Compliance - Investigator, Deviations. You will author and revise deviation records and related cGMP documents, collaborating with Manufacturing and Quality to ensure timely, compliant completion. You will support audits and drive corrective actions while promoting a strong compliance culture.

Shift: Mon–Friday, core hours 9am–4pm. Location: Madison, WI. 100% onsite.

Qualifications

• 7+ years of related experience with a STEM degree
• Experience in writing deviations and with Root Cause Analysis and CAPAs
• Proficiency with quality systems and cGMP principles
• Experience supporting internal and client audits, and SOP writing

Responsibilities

• Author and revise deviation records, CAPAs, and related cGMP documents
• Collaborate with manufacturing and quality systems to ensure compliance
• Lead inspections readiness activities and teams
• Track and report status of open investigations
• Support audits and client inquiries regarding deviations and corrective actions
• Develop and revise Standard Operating Procedures to close gaps
• Participate in biomanufacturing compliance meetings

Skills

Deviation writing

Root cause analysis

cGMP knowledge

Audits support

Documentation writing

Education

Bachelor's degree in STEM

MS/PhD in technical discipline

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

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.

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 a Lead - Biomanufacturing Compliance - Investigator, Deviations to join our team. In this role, you will be responsible for authoring and revising deviation records and related cGMP documents while ensuring timely and accurate completion. You will collaborate with manufacturing and quality systems, support audits, and contribute to a strong compliance culture. This position offers the chance to actively participate in inspection readiness and continuous improvement initiatives.

Shift: Mon-Friday, core hours 9am-4pm

Location: Madison, WI

100% Onsite

The Role

• Author and revise complex deviation records, preventative actions, and other related cGMP documents in a timely manner.
• Apply working knowledge of upstream, downstream, materials management, production facility, systems, and technologies to ensure accurate completion of responsibilities.
• Track, monitor, and provide timely, accurate information regarding the status of open investigations.
• Lead initiatives to improve process compliance culture, including ongoing cGMP understanding and application.
• Lead Inspection Readiness activities and teams.
• Write and revise Standard Operating Procedures, proactively identifying gaps.
• Provide support to internal and client audits regarding the status of deviations and Corrective and Preventive Actions.
• Exhibit professional behavior with internal and external associates consistent with company policies and practices.
• Participate regularly in team meetings for biomanufacturing compliance support.
• Perform other duties as assigned.

Minimum Requirements

• High School Diploma or GED with at least 7+ years of related experience, or an Associate’s degree in a STEM field with 6+ years of related experience.
• 3+ years of experience required with a Bachelor’s degree in a STEM‑related field, or an MS/PhD in a technical discipline without formal experience.
• Experience in deviation writing and with Root Cause Analysis and Corrective and Preventive Action implementation.
• Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and Unicorn®.
• Ability to apply cGMP principles and best practices to ensure compliant, high‑quality execution of procedures.
• Foundational knowledge of manufacturing and laboratory operations, with the ability to learn new processes and techniques.
• Experience with deviation investigations, including corrective and preventive actions.
• Experience authoring and editing Standard Operating Procedures and related documentation.
• Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with Environmental Health and Safety responsibilities.

Preferred Skills & Background

• Experience in large‑scale manufacturing in upstream or downstream for biological drug products in a GMP environment.

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 plus 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.

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