Senior Validation Engineer: Aseptic Cleaning Lead

MilliporeSigma

Indianapolis (IN)

On-site

USD 111,000 - 167,000

Full time

4 days ago

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Benefits offered by this job

Health insurance

PTO

Retirement contributions

Bonuses possible

Job summary

MilliporeSigma in Indianapolis is seeking a Sr. Validation Engineer to own the validation program for a complex aseptic manufacturing site, focusing on the cleaning validation program.

You will author and execute validation protocols spanning process, equipment, facility, utilities, and computerized systems with substantial autonomy. You will lead cross-functional validation projects, develop validation master plans, and support media fills while reviewing data for management approval to ensure

Qualifications

B.S. in science or engineering with 7+ years validation in aseptic pharma.
Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning and sterility assurance.

Responsibilities

Lead and execute validation activities across aseptic manufacturing.
Develop and implement validation master plans and protocols.
Coordinate cross-functional validation projects and change controls.
Support media fills and revalidation activities.

Skills

Validation experience

Aseptic processes

Process equipment

Quality systems

Regulatory compliance

Statistical analysis

Education

B.S. in science or engineering

Tools

Kaye Validator

Val Probe

PLC

Temperature standards

Pressure standards

Job description

MilliporeSigma in Indianapolis is seeking a Sr. Validation Engineer to own the validation program for a complex aseptic manufacturing site, focusing on the cleaning validation program.

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