Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
This role
The Senior Process Validation Engineer is a key member of the Technical Services organization, responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment. This role focuses on process validation strategy, execution, lifecycle management, and maintaining the validated state to ensure compliant, robust, and inspection‑ready operations.
The Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement risk‑based approach that support safe, reliable, and scalable sterile drug product manufacturing. This position is full time and based onsite at the Simtra Bloomington facility.
The responsibilities
Provide technical and strategic leadership for process validation of new and existing sterile injectable manufacturing processes, including formulation, compounding, filtration, aseptic filling, lyophilization, and terminal sterilization, as applicable
Own and drive lifecycle process validation strategy, ensuring risk‑based, scientifically justified approaches aligned with FDA/EMA guidance, ICH expectations, and internal quality standards
Lead the development, review, and approval of key validation deliverables, including Process Validation Master Plans, risk assessments, protocols, control strategy elements, and final validation summary reports
Set validation direction and standards for parameters, sampling strategies, acceptance criteria, and statistical approaches; ensure consistent application across products, programs, and manufacturing areas
Serve as the primary validation interface with Manufacturing, Quality, Engineering, and external clients to ensure end‑to‑end process readiness for PPQ and commercial manufacturing
Lead process validation planning and execution for technology transfers, including assessment of development history, identification of validation gaps, definition of validation scope, and readiness for PPQ execution
Provide senior oversight and technical guidance for equipment, facility, and utility qualification activities, ensuring robust alignment with process validation requirements
Provide expert validation impact assessments for changes related to process, equipment, raw materials, analytical methods, and facilities, supporting change control and regulatory commitments
Establish and oversee continued process verification programs
Act as on‑the‑floor validation lead during PPQ execution, process confirmation runs, technology transfer campaigns, and high‑risk or high‑visibility manufacturing operations
Ensure validation documentation is inspection‑ready, supporting internal audits, client audits, and global regulatory inspections
Serve as a SME during regulatory inspections and client audits; lead inspection preparation, participate in interviews, and support responses to inspection observations
Continuously improve validation practices, incorporating lessons learned, regulatory trends, and industry best practices to enhance efficiency, compliance, and product quality
Required qualifications
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
Preferred qualifications
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]
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Additional Benefits
Short and Long-Term Disability Insurance
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
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.
Equal Employment Opportunity
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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