Sr. Process Validation Engineer

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
• 5–8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environment
• Strong understanding of sterile injectable manufacturing processes and aseptic processing principles
• Solid working knowledge of cGMP requirements and validation lifecycle concepts
• Demonstrated experience authoring and executing process validation protocols and reports

• Experience working in a CDMO environment and sterile injectable drug product manufacturing
• Familiarity with equipment and facility qualification and CSV validation
• Experience supporting regulatory inspections and client audits as a validation SME
• Knowledge of continued process verification, process capability analysis, and lifecycle management
• Experience working with electronic validation systems, MES, or electronic batch records

Physical / safety requirements:

• Occasional overtime may be required, including evenings or weekends to support validation execution or manufacturing schedules
• Position requires extended periods of sitting with routine walking and standing in manufacturing areas
• Must be able to qualify for classified manufacturing area gowning as applicable
• Must be able to wear required personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Life and AD&D Insurance

• 401(k) Retirement Savings Plan with Company Match

• Paid Holidays

• Paid Parental Leave and more

• Community and Volunteer Service Program
• Additional Benefits
• Short and Long-Term Disability Insurance

• Vision Coverage
• Accident
• Critical Illness

• Legal and more

• Workout Facility
• Cafeteria
• Credit Union

[1] Current benefit offerings are in effect through 12/31/26

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.

It may not be inclusive of all the duties and responsibilities of the job.

Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal opportunity employer.

Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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