Process Validation Associate III

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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. 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.

This role : This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards / best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Sr. Manager, Technical Services, and is 100% onsite at the Bloomington, Indiana facility.

The responsibilities :

• Supports the process validation program
• Interacts with the client and client team to define process validation scope
• Designs and executes the appropriate development Technical Studies to define process parameters
• Creates a risk assessment of the process to be validated
• Creates process validation protocols
• Conducts and coordinates process performance qualification (PPQ batch) execution for new and existing products
• Prepares validation summaries
• Uses statistical tools to analyze process validation data
• Performs annual reviews / continued process verification (CPV) of validation projects
• Investigates and executes validation related Corrective and Preventive Actions (CAPA)
• Demonstrate ability to communicate effectively at all levels
• Non-conformance Report (NCR) investigation owner for process validation related, as needed
• Participates in regulatory, client and internal audits

Desirable qualifications :

Physical / Safety Requirements :

In return, you'll be eligible for [1]

[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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