Senior Validation Engineer - Aseptic Cleaning Lead

Emd Group; Indianapolis (IN); On-site; USD 111,000 - 167,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Job summary

Emd Group in Indianapolis, Indiana is seeking a Sr. Validation Engineer to own validation activities across an aseptic pharmaceutical manufacturing site, with a primary focus on the cleaning validation program.

You will research, author, coordinate, and execute validation protocols covering process, equipment, facility, utilities, computerized systems, and cleaning, with considerable autonomy. The role requires 7+ years in validation within an aseptic pharmaceutical setting and a BS in science

Qualifications

• 7+ years of validation experience in an aseptic pharmaceutical setting.
• Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning and sterility assurance.

Responsibilities

• Own validation activities across a complex aseptic manufacturing site, focusing on cleaning validation.
• Research, author, coordinate and execute validation protocols for process, equipment, facility, utilities, computerized systems, and cleaning.
• Review and summarize data for management approval and support change controls and deviations.
• Develop validation master plans and lead cross-functional projects, including media fills.

Skills

Validation experience

Aseptic operations

Equipment cleaning

Education

B.S. in science or engineering

Tools

Kaye Validator

Val Probe

PLC

Job description

Emd Group in Indianapolis, Indiana is seeking a Sr. Validation Engineer to own validation activities across an aseptic pharmaceutical manufacturing site, with a primary focus on the cleaning validation program.

You will research, author, coordinate, and execute validation protocols covering process, equipment, facility, utilities, computerized systems, and cleaning, with considerable autonomy. The role requires 7+ years in validation within an aseptic pharmaceutical setting and a BS in science