Process Validation Associate III

Simtra BioPharma Solutions•Bloomington, IN

6d•Onsite

About The Position

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. 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 Process Validation Sr. Manager.

Requirements

Bachelor’s degree required, preferably in a science or engineering-related field.
Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
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. May be considered a subject matter expert (SME) in various disciplines.
Must be able to identify opportunities for optimization of processes within the department or the plant.
Ability to work independently or in teams.

Responsibilities

Support and maintain the process validation program.
Develop, revise, and maintain process validation procedures, protocols, and summary reports.
Partner with clients and internal teams to define validation scope, requirements, and objectives.
Design, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.
Perform risk assessments to support process validation activities.
Plan, coordinate, and execute process validation activities for new and existing products.
Analyze validation data and prepare documentation to support validation conclusions.
Conduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.
Lead or support investigations related to validation activities, including Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
Monitor regulatory requirements and industry best practices to ensure compliance and continuous improvement.
Create and maintain visual management tools and controls for the Process Validation group.
Serve as a Subject Matter Expert (SME) for process validation during regulatory, client, and internal audits.
Develop industry expertise and project proficiency while working independently on assigned initiatives.
Identify and implement opportunities to optimize departmental processes and improve operational efficiency.