Senior Process Validation Engineer - Sterile Injectables

Simtra US LLC; Bloomington (IN); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Day One Benefits

401(k) Plan

Paid Time Off

Education Assistance

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Senior Process Validation Engineer to lead and support validation activities for sterile injectable manufacturing processes in a regulated CDMO environment. This role collaborates with Manufacturing, Quality, Validation, Engineering, Tech Transfer, and Regulatory teams to ensure compliant, robust, and inspection-ready operations.

The Senior Process Validation Engineer will drive validation strategy, lifecycle management, and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences or related technical discipline.
• 5–8+ years in process validation or CQV within a regulated pharmaceutical environment.
• Strong understanding of sterile injectable manufacturing and GMP validation lifecycles.
• Experience authoring and executing validation protocols and reports.

Responsibilities

• Lead and support validation activities for sterile injectable manufacturing processes.
• Develop, review, and approve validation deliverables and risk assessments.
• Drive lifecycle validation strategy and PPQ readiness with cross‑functional teams.
• Provide on‑floor validation leadership during PPQ execution and tech transfers.
• Ensure inspection‑ready validation documentation for audits and inspections.

Skills

Process validation

Regulatory knowledge

Technical leadership

Aseptic processing

Documentation & reports

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

MS&T

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Senior Process Validation Engineer to lead and support validation activities for sterile injectable manufacturing processes in a regulated CDMO environment. This role collaborates with Manufacturing, Quality, Validation, Engineering, Tech Transfer, and Regulatory teams to ensure compliant, robust, and inspection-ready operations.

The Senior Process Validation Engineer will drive validation strategy, lifecycle management, and