Job Reference: JO-1912-64888_1583928569
Our client is a global leader in delivering therapeutics that provide meaningful advances to patient's lives by targeting conditions that lack effective therapies and is responsible for creating drugs and medical devices for clinical trials as well as the commercial market. Come join their team and make a meaningful impact on patients' lives.
The new incubnet will collaborate with internal groups and CMOs to ensure successful on-time packaging introduction, which includes package testing, artwork approval, overseeing machinery IQ, OQ, and PQ, and ensuring compliance with specifications and regulatory guidelines.
- Develops strategies to implement changes to processes.
- Provide Packaging Engineering support for the development and launch of new products.
- Lead on-site implementation of changes and packaging-related launch activities at CMOs.
- Team member for technical packaging projects on cross-functional project teams.
- Evaluate new packaging process or packaging to increase productivity, meet packaging objectives, and/or reduce costs without sacrificing quality.
- Design, test, and implement secondary, tertiary, and selected primary packaging components.
- Author SOPs, work procedures, packaging specifications, package design testing protocols, and oversee testing of the packaging components and packaging systems.
- Identify new packaging suppliers as needed. Justify, arrange qualification, and participate in audit as required. Work with and travel to contract sites to jointly develop package systems.
- Approve artwork from a technical perspective
- Will be a member of multidisciplinary project teams and be called on to lead teams for tasks that are focused on packaging issues.
- Apply knowledge of FDA and ISO requirements related to packaging, ensuring robust package verification and approval.
- Evaluate and implement new technologies to enhance productivity, safety, and meet requirements.
- Initiate Change Control, Deviations, and CAPAs through the Trackwise system.
Skills & Educational Requirements
- Minimum 2 years as a Packaging Engineer in the Biotech/Pharmaceutical industry.
- Degree in Engineering, Science or Business.
- Independent thinker with demonstrated skills working in teams or leading project teams
- Ability to multi-task and manage timelines
- Experience working with packaging artwork is a plus.
- Working knowledge of packaging manufacturing processes
- Proficient in MS Office: Word, Excel, Outlook, PowerPoint, Project CAPE or TOPS
- Excellent organizational, interpersonal communication, and problem-solving skills.
- Experience with CAPA, FMEA, RCA tools.
- Highly developed organizational and project management and influencing skills.
- Process development or technology transfer experience preferred.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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