Simtra BioPharma Solutions
Process Validation Associate III
Bloomington, Indiana, United States · Mid
Sponsorship not specifiedDetected 12 days ago
ExcelGMPMicrosoft Office
About the role
- This position reports to the Process Validation Sr.
- Plan, coordinate, and execute process validation activities for new and existing products.
- Conduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.
Responsibilities
- Support and maintain the process validation program.
- Develop, revise, and maintain process validation procedures, protocols, and summary reports.
- Design, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.
- Perform risk assessments to support process validation activities.
- Analyze validation data and prepare documentation to support validation conclusions.
- Lead or support investigations related to validation activities, including Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
- Create and maintain visual management tools and controls for the Process Validation group.
- Identify and implement opportunities to optimize departmental processes and improve operational efficiency.
- Partner with clients and internal teams to define validation scope, requirements, and objectives.
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- Bachelor's degree required, preferably in a science or engineering-related field.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
- Ability to communicate effectively at all levels.
- Sound industry knowledge, project proficiency, and be able to work independently.
- Must be able to identify opportunities for optimization of processes within the department or the plant.
- Ability to work independently or in teams.
- Must be able to gown for Grade C environments
- Use of hands and fingers to manipulate office equipment is required
- Develop industry expertise and project proficiency while working independently on assigned initiatives.
Nice to have
- Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
Compensation
- Conduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.
Benefits
- 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.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
Company info
- This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices.
Equal 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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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.