Lead - Biomanufacturing Compliance - Investigator, Deviations

Catalent Pharma Solutions; Madison (WI); Presencial; USD 110 000 - 150 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Defined career path

Diverse, inclusive culture

Career growth opportunities

Competitive PTO and holidays

Medical, dental, vision benefits

Resumo da oferta

Catalent in Madison, WI is seeking a Lead - Biomanufacturing Compliance - Investigator, Deviations to manage deviation records and cGMP documents onsite. You will collaborate with manufacturing and quality systems, support audits, and drive inspection readiness and continuous improvement initiatives.

The role emphasizes SOP development, CAPA activities, and regulatory compliance within a GMP manufacturing environment.

Qualificações

• Experience writing deviations and with Root Cause Analysis and CAPA implementation.
• Ability to apply cGMP principles to ensure compliant, high-quality execution.
• Experience with SOPs and related documentation.

Responsabilidades

• Author and revise deviation records and cGMP documents.
• Lead inspections readiness activities and teams.
• Provide support to audits and CAPA status.
• Write and revise Standard Operating Procedures.
• Collaborate with manufacturing and quality systems groups.

Conhecimentos

Deviation writing

Root Cause Analysis

Corrective Actions

Preventive Actions

SOP writing

Audit readiness

Quality systems knowledge

Formação académica

High School Diploma or GED

Associate degree in STEM

Bachelor’s degree in STEM

MS/PhD in technical discipline

Ferramentas

TrackWise

ComplianceWire

JD Edwards

Unicorn

Microsoft Office

Descrição da oferta de emprego

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.


• 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.

The Candidate 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.

Benefits

• 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.

Equal Opportunity Statement

Catalent is an Equal Opportunity Employer, including disability and veterans.

Accommodation Statement

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 [e-mail]. 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.