Computer System Validation (CSV) - IT Associate II

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.



Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

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 Computer Systems Validation (CSV) - IT Associate II role supports the global Quality CSV group including determining validation strategies and writing validation documents. This role also serves as a resource to other Validation Associates and other departments in the organization. This position reports to the Director of CSV Quality & Compliance and is a remote position.

The responsibilities:

• Validation Documentation Support - validation documentation, including Validation Plans, URS (User Requirement Specifications), FRS (Functional Requirement Specifications), Test Scripts (IQ, OQ, PQ), and Validation Reports in compliance with GxP, FDA, EU and other regulatory standards
• Testing and Execution - Support the execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Supports - Document test results and deviations, ensuring issues are properly logged and resolved
• Compliance & Regulatory Adherence - Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, and company SOPs. And Assist in audits and regulatory inspections by providing required validation documents
• Risk Assessment & Change Control - Participate in risk assessments related to computerized system and Support change control processes, ensuring all system changes are validated properly
• System & Data Integrity - Ensure data integrity principles (ALCOA ) are applied to all validation processes. And Monitor system performance and report compliance issues
• Collaboration & Training - Work with IT, QA, and business teams to understand system requirements and validation needs. And Assist in training users on validated systems and proper documentation practices
• Continuous Improvement to keep up to date with industry best practices in CSV and regulatory changes. And Assist in process improvements for more efficient validation activities
  
  
  
  

Required qualifications:

• BS in Engineering, Science, or a related field
• 3 years experience in qualifying/validating computer systems, including writing IQ, OQ, PQ documents, in a pharmaceutical environment
• Experience writing risk assessments, user requirements, SOPs, and work instructions in a GMP, GXP environment
• Experience with enterprise systems: QMS, Trackwise, Veeva, and COMET
• Minimal domestic travel (10%) to US site/facility
• Knowledge of regulatory standards, including US CFR (FDA regulations) and EMA guidelines application to pharmaceutical manufacturing and quality systems
  
  
  
  

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
• Short and Long-Term Disability 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
• Employee Ownership Plan
• Additional Benefits
• 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 12/31/25

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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