Validation Engineer I - Biotech QA & Compliance

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

Benefits offered by this job

Tuition Reimbursement

Benefits from day one

Job summary

Catalent, Inc. is seeking an Engineer I - Engineering, Validation in Madison, WI to uphold QA and validation standards across equipment and systems. You will lead validation activities, collaborate with cross-functional teams, and ensure compliant documentation and processes.

The role emphasizes oversight of validation programs, commissioning, qualification, and continuous improvement within a 100% onsite environment. Strong background in cGMP and validation methodologies is required.

Qualifications

• Bachelor's or Master’s in a technical field with relevant validation experience.
• Strong knowledge of cGMPs and validation standards (ISPE/ASTM).
• Experience drafting, reviewing, executing, and approving validation protocols and reports.
• Experience supporting validation activities in regulated pharma/biotech environments.
• Experience with change controls, deviations, CAPAs, investigations, and risk assessments.

Responsibilities

• 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.

Skills

cGMP knowledge

Validation experience

Change controls

CAPAs

Risk assessments

Documentation

Education

Bachelor's degree in technical field

Master's degree in technical field

Tools

ISPE standards

ASTM standards

21 CFR Part 11

Job description

Catalent, Inc. is seeking an Engineer I - Engineering, Validation in Madison, WI to uphold QA and validation standards across equipment and systems. You will lead validation activities, collaborate with cross-functional teams, and ensure compliant documentation and processes.

The role emphasizes oversight of validation programs, commissioning, qualification, and continuous improvement within a 100% onsite environment. Strong background in cGMP and validation methodologies is required.