Packaging Validation Associate II - 1st Shift

Packaging Validation Associate II - 1st Shift

Bloomington, Indiana, United States

Simtra Bio Pharma 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  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.

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.

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The Packaging Validation Associate I supports all aspects of the packaging process. This includes packaging development, equipment validation and general finishing operations. The position supports Packaging Development including the defining of packaging requirements, materials selection, package design, prototype development, package testing and the development of all related packaging documentation. It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support.

This position reports to the Manager, Packaging Validation.

• Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
• Develops and executes Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc.
• Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
• Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders.
• Formulates and recommends validation procedures and technical work in accordance with project and business objectives
• Participates in client and regulatory audits
• Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications
• Acts as Change Control Management (CCM) Owner, Non-Conformance and OCR (Out of Control Report) author
• Identifies and implements changes to Automated Inspection Machines
• Reviews and approves Packaging Technical Services documents

• Bachelor’s degree in science or engineering related area is preferred or a minimum of 5 years manufacturing experience with 2 years of leadership experience required.
• In-depth process knowledge of related manufacturing equipment and process preferred
• Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
• Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.
• Proficiency in Microsoft Word, Excel, and…