Validation Engineering Supervisor – CQV & QA

Catalent, Inc.; Kentucky; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive PTO

8 paid holidays

Medical, dental, and vision benefits (

Job summary

Catalent, Inc. in Madison, WI is seeking a Supervisor - Engineering, Validation to lead a team of validation professionals and ensure CQV programs meet regulatory standards.

You will oversee validation master plans, protocols, and reports, participate in audits, and drive continual improvement while partnering with QA, Manufacturing, Facilities, Engineering, and customers onsite. The role requires deep knowledge of FDA, ICH, EMA guidance, cGMP compliance, and change control processes, with

Qualifications

• Doctorate in STEM with 2+ years of related experience, or Master's with 4+ years, or Bachelor's with 5+ years.
• 0–2 years of leadership experience.
• Experience in Commissioning, Qualification, and Validation (CQV).
• Knowledge of validation lifecycle management.
• Experience with Change Control impact assessments.
• Experience in requalification and periodic reviews.
• Proficiency in validation protocol and report writing and execution.
• Strong understanding of cGMP.
• Knowledge of FDA, ICH, and EMA regulations.
• Ability to interpret regulatory guidance and validation requirements.
• Experience leading validation projects and initiatives.

Responsibilities

• Lead a team of Validation professionals.
• Maintain Validation Master Plans.
• Review and approve validation protocols and reports.
• Support commissioning, qualification, and validation activities.
• Review Change Controls.
• Manage requalification programs.
• Participate in audits and inspections.
• Drive continuous improvement initiatives.
• Serve as Validation SME.
• Coordinate with QA, Manufacturing, Facilities, Engineering, and customers.
• Provide technical training and support.

Skills

CQV

Validation lifecycle management

Change Control

Requalification

Regulatory knowledge

Validation protocol/report writing

cGMP

Team leadership

Audits & inspections

Training and mentorship

Education

PhD in STEM

MS in STEM

BS in STEM

Job description

Catalent, Inc. in Madison, WI is seeking a Supervisor - Engineering, Validation to lead a team of validation professionals and ensure CQV programs meet regulatory standards.

You will oversee validation master plans, protocols, and reports, participate in audits, and drive continual improvement while partnering with QA, Manufacturing, Facilities, Engineering, and customers onsite. The role requires deep knowledge of FDA, ICH, EMA guidance, cGMP compliance, and change control processes, with