Senior Process Validation Engineer, Sterile Injectables

Simtrabps; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Flexible Spending Accounts

Time Off Program

Job summary

Simtrabps is seeking a Senior Process Validation Engineer to lead validation activities in sterile injectable manufacturing at its Bloomington, Indiana facility. The role involves strategic leadership in process validation and maintaining compliance with quality standards.

The ideal candidate will have 5–8+ years of relevant experience and a Bachelor's degree in Engineering or Life Sciences. This position offers an opportunity to work closely with multiple teams to ensure safe, reliable, and scalable drug product manufacturing.

Qualifications

• 5–8+ years of experience in process validation within a regulated pharmaceutical environment.
• Strong understanding of sterile injectable manufacturing processes.
• Demonstrated experience authoring and executing process validation protocols.

Responsibilities

• Lead validation activities for sterile injectable manufacturing processes.
• Own lifecycle process validation strategy aligned with FDA/EMA guidance.
• Serve as the primary validation interface for process readiness.

Skills

Process validation

Aseptic processing

CQV

cGMP compliance

Technical leadership

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Simtrabps is seeking a Senior Process Validation Engineer to lead validation activities in sterile injectable manufacturing at its Bloomington, Indiana facility. The role involves strategic leadership in process validation and maintaining compliance with quality standards.

The ideal candidate will have 5–8+ years of relevant experience and a Bachelor's degree in Engineering or Life Sciences. This position offers an opportunity to work closely with multiple teams to ensure safe, reliable, and scalable drug product manufacturing.