Packaging Validation Associate II - 1st Shift

Simtra BioPharma Solutions•Bloomington, IN

About The Position

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market. Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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. In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies. It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide. The Packaging Validation Associate II supports all aspects of the inspection, labeling and packaging process. This includes development, equipment validation and general operations support. The position supports Packaging Development including the defining of inspection/labeling/packaging requirements, materials selection, package design, prototype development, package testing and the development of all related documentation. It also supports Packaging Validation including inspection/labeling/packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support. This position reports to the Manager, Packaging Validation.

Requirements

Bachelor’s degree in a science, engineering, or technical related area is required.
Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.
Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, BPLM, Trackwise, etc.)
Manages time effectively and independently within assigned responsibilities
Ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines
Operates as a self-starter having the ability to complete tasks with minimal direction from manager
Exhibits a sense of urgency to meet timelines and key milestones
Possesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing ones
Must be able to lift up to 25 lbs.
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position requires sitting/standing for long hours, but may involve walking or standing for periods of time
Must wear appropriate Personal Protective Equipment as applicable
Must fully understand company safety rules and regulations

Nice To Haves

In-depth process knowledge of vision systems and related manufacturing equipment /process preferred
Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred

Responsibilities

Manages multiple projects providing technical support for inspection/labeling/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), Site Acceptance Tests (SAT), and User Requirement Specifications (URS)
Participates in and leads 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 regulatory audits and leads Client and Vendor tours.
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 Subject Mater Expert (SME), Change Control Owner, Non-Conformance and OCR (Out of Control Report) author
Identifies and implements new project onboarding, process improvements, and changes to Automated Inspection, Labeling, and Packaging Machines
Reviews and approves Packaging Technical Services documents