Validation Engineer I - QA, Biopharma (Madison, Onsite)

Catalent, Inc.; Kentucky; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive PTO and 8 paid holidays

Benefits from day one (medical, dental

Tuition Reimbursement

Job summary

Catalent, Inc. in Madison, WI is seeking an Engineer I - Engineering, Validation to join our QA‑focused team on a 100% onsite basis.

The role supports validation activities to ensure compliance with regulatory standards and internal quality guidelines, overseeing validation programs, commissioning and qualification of equipment, and collaborating with cross‑functional teams to maintain high quality and compliance.

Qualifications

• Bachelor's degree in a technical field (Biology, Biotechnology, Engineering, or related) with 7+ 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

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 concepts

Risk assessment

Education

Bachelor's degree in a technical field

Master's degree in a technical field

Tools

ISPE standards

ASTM standards

Job description

Catalent, Inc. in Madison, WI is seeking an Engineer I - Engineering, Validation to join our QA‑focused team on a 100% onsite basis.

The role supports validation activities to ensure compliance with regulatory standards and internal quality guidelines, overseeing validation programs, commissioning and qualification of equipment, and collaborating with cross‑functional teams to maintain high quality and compliance.