- Develop specifications for serialization processes
- Design, manage, install, commission and qualify line serialization systems to meet the client requirements for serialization regulations
- Incorporate flexibility with different levels of serialization
- Incorporate vision based systems into existing packaging lines to aid in the process of serialization implementation
- Manage vendor selection process and integrate serialization solution on the lines
- Identify, define and manage the packaging component changes (change controls and SOPs) needed to support the serialization
- Deliver the end result of a program that accurately represents and reports the complete history of a product’s chain of custody, from manufacturing to the point of dispense
- Support equipment qualification and packaging process validation documentation development for serialization projects.
- Support execution of validation protocols.
- Responsible for ensuring compliance with 21 CFR and other Federal (FDA, DEA, EPA, OSHA), State and local regulations and adherence to all company policies and procedures relating to Good Manufacturing Practices, Health, Safety & Environmental Protection.
Commissioning and Qualification Role
- Author and execute C&Q documents
- Serve as lead project SME for document content and approval
This position requires a minimum of a Bachelor’s degree in relevant Engineering or Scientific degree; advanced degree (MS or PhD) preferred.
- 5+ years of experience in the area of serialization or an affiliated technical area
- Serialization Software experience (Systech, Optel, Antares)
- IT and Networks, Hardware and Computer Systems Set up
- SQL Server
- Knowledgeable in serialization test procedures and shipping studies
- Be involved in full cycle of serialization from authentication through complete track and trace (unit level aggregation to cases to pallets)
- Keep abreast of technology and innovations in serialization as related to pharmaceutical packaging and provide technical leadership on packaging projects.
- Must have special, in-depth knowledge of the subject-matter area as well as good knowledge of surrounding areas
E.g., knowledge of the serialization process as a whole, history of serialization, the related technology, regulations/trends/best practices, hardware/software, business aspects
Capacity to make independent sound decisions and independently manage priorities
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
Experience with and tolerance for high levels of challenge and change
Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the organization (C-Level required for higher level Automation Engineer)
This position requires a cross-functional working relationship with peer engineers, clients, OEMs, and contractors in orders to meet project goals and deadlines.
This position may have any direct report responsibilities.
Work Environment and Physical Demands
FLSA professional position paid on salary basis, where project requirements and tight client deadlines may require workweeks in excess of 40 hours (including weekends or holidays)
Work is often performed at our Fishers Headquarters (25% travel) with PPE required at some customer locations and indirect exposure to drug products at some customer locations.
Many client sites require specific safety training and adherence to OSHA requirements.
Work is performed in and around automated equipment, and cabinets in a manufacturing environment which requires standing, crouching, reaching and leaning over to work on and inspect equipment from many angles.
Lifting requirements – 35 lbs. per OSHA requirements
Walking (including in/around automated equipment and electrical cabinets) 1-2 miles is possible (carrying laptop and materials)
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