Packaging Engineer CAR T – Celgene – WA, USA
This position is responsible for management of packaging projects including but not limited to the creation of engineering documents (drawings, specifications, protocols, reports, change controls, etc), execution of packaging test plans, execution of shipping validation studies, development of labeling solution, and management of external packaging vendors and internal stakeholders. Candidate is expected work on cross functional teams and to exhibit ownership and deliver on-time results while optimizing quality and performance. This is a unique opportunity to work on packaging of novel cell therapy products within Global Manufacturing Science and Technology Organization.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Demonstrated skills in project management with the ability to independently plan, prioritize, schedule and coordinate multiple projects simultaneously
- Excellent analytical, critical-thinking, and creative problem-solving skills, with ability to analyze information / situations efficiently.
- Strong skills in technical writing.
- Attention to details with focus on quality.
- Flexible in adapting to changing project priorities and work assignments.
- Ability to work under pressure with demanding deadlines.
- Ability to think strategically and to translate strategy into action plans.
DUTIES AND RESPONSIBILITIES
- Supports packaging engineer team lead on development of packaging and shipping validation test plans, generating test protocols, executing testing internally and with external test labs, and generating test reports.
- Collaborates with development team to ensure all novel primary and secondary packaging materials and components meet technical, legal, and regulatory requirements.
- Liaisons with manufacturing and operational sites to support packaging and shipping related deviation investigations/CAPAs, impact assessments, and change controls.
- Creates and maintains packaging specifications and artworks for primary packaging, secondary packaging, and shipping materials and components.
- Creates and maintains packaging labelling and secondary packaging artworks and layouts.
- Maintains internal temperature monitoring program for temperature-controlled shipping systems both domestically and globally.
- Develops and maintain internal packaging test methods, capabilities, and equipment.
- Ensures safe and compliant cGMP operations and activities.
- Stays current with industry standards and trends, drives continuous-improvement and optimization projects within the packaging engineering and larger gMSAT teams.
- Ensures strong cross-functional and inter-team communication and relationships to achieve common project goals.
EDUCATION AND EXPERIENCE
- BA/BS degree required (Packaging Science or Packaging Engineering preferred)
- 3 – 5 years in Pharma industry experience or equivalent experience.
- Proficient with MS Word, PowerPoint, Excel, Visio, and Projects.
- Experience with Cold Chain logistics and temperature-controlled shipping.
- Experience working with external packaging and test lab vendors.
- Experience with ASTM and ISTA packaging test standards and methods.
- Experience with AutoCAD/ArtiosCAD, Adobe Illustrator and Photoshop.
- Experience with cGMP’s, cGDP’s, and Data Integrity.
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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