Lead Aseptic Validation Engineer – Cleaning & Compliance

Millipore Corporation; Indianapolis (IN); On-site; USD 111,000 - 167,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in the United States seeks a Sr. Validation Engineer to own and execute validation activities across a complex aseptic manufacturing site, with a primary focus on cleaning validation.

You will research, author, coordinate, and execute validation protocols covering process, equipment, facility, utilities, and computerized systems. In this role, you will lead data reviews for management, perform revalidations, support change control, and develop validation master plans while

Qualifications

• 7 years validation experience or equivalent with 9 years if two-year degree
• Experience in aseptic pharmaceutical setting focused on equipment cleaning
• Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems and process control systems

Responsibilities

• Lead and execute validation activities across a complex aseptic manufacturing site
• Focus on cleaning validation; research, author, coordinate and execute validation protocols
• Review and summarize data for management approval; perform revalidations and support change control

Skills

Validation

aseptic pharma

Equipment cleaning

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Tools

Kaye Validator

Val Probe

PLC

Job description

MilliporeSigma in the United States seeks a Sr. Validation Engineer to own and execute validation activities across a complex aseptic manufacturing site, with a primary focus on cleaning validation.

You will research, author, coordinate, and execute validation protocols covering process, equipment, facility, utilities, and computerized systems. In this role, you will lead data reviews for management, perform revalidations, support change control, and develop validation master plans while