Description
Key features -- Develop and review Product and Process Requirements (PRDs)
- Development of harmonized User Requirement Specifications (URS) specific to Packaging Processes
- Lead the industry research and selection process for the best in class equipment suppliers using diverse evaluation tools, critical thinking and facilitating cross functional teams.
- Facilitating the capital procurement process related to packaging equipment and systems.
- Lead the Design, qualification and implementation of packaging equipment in a collaborative environment within Amgen's global network.
- Development and review of Design Qualification Documentation such as Functional Design Specification (FDS), Hardware Design Specifications (HDS), Software Design Specification (SDS), Factory Acceptance Test (FAT) and other Engineering Acceptance Testing documentation.
- Support for testing and evaluation leading to recommendation and selection of primary and secondary packaging materials on the equipment.
- Recommend and support design and implementation of manual, semi automated and fully automated systems to assure Operational Excellence (OE).
- Competent with AutoCAD or similar software application to create, modify and approve engineering drawings.
- Support technology transfer from clinical to commercial or from site to site for packaging equipment processes.
- Support line trials and packaging validation activities prior to introduction of any new or change in equipment.
- Ensures camp and regulatory compliance are met.
- Ensures that change control procedures are followed working with QA and Regulatory to implement changes.
- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.
Qualifications
- Doctorate degree OR
- Master's degree & 3 years of directly related experience OR
- Bachelor's degree & 5 years of directly related experience
- Demonstrated leadership in a wide range of related technologies with strong fundamental knowledge of primary and secondary packaging systems & processes, manufacturing fill finish equipment & processes, material science, and quality systems are essential.
- The successful candidate will have excellent organizational, project management, technical, problem solving and communication (written &
verbal) skills.
- Must have demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule.
- Demonstrated hands on experience working in Asia, Europe and other emerging countries will be considered a plus.
To find out more about Real please visit www.realstaffing.com