• Prospect and define new suppliers
• Organize, schedule, participate and document (on the specific form) the packaging material tests
• Assist with new projects and improvements related to packaging and packaging materials

• Start and manage the flow of the creation/review/approval/release of artwork and specification;
• Request new codes of packaging material and perform the follow-up of the creation of the codes;
• Open change management related to change of artwork and specification;
• Project manage the implementation and timing of the PMD changes
• Represent Packaging Material Development (PMD) on Change Management (CM) meetings.

• Assist in project improvement initiatives that may include Packaging, Operations and QC Incoming.

• Perform the draft, review and approval step of technical documents as SOPs, technical drawings, artworks, specifications, analytical methods and registers.
• Perform the follow-up of the PMD documents.
• Send the artwork/PMS/TD to the packaging material suppliers as part of the quoting process.
• Assist in technical evaluations of packaging material deviations.
• Approve electronic print proofs.

• Assist the PMD Manager as needed with syringe component support.  This may include:
  • Aid in optimizations of testing and material flow to increase efficiencies, safety/ergonomics while maintaining Quality.
  • Actively participate in safety-related activities (audits, hazard reviews, etc.) to drive ongoing safety improvement.
• Interact with Regulatory Agencies during audits and assessments.
• Assist in troubleshooting efforts to resolve more difficult process and operational challenges.
• Utilize formal problem solving techniques, including Root Cause Analysis, to resolve process deviations.
• Assist with implementation of corrective actions arising from deviation CAPAs.
• Participate in Annual Product Reviews for systems.
• Assist the PMD team to drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with processes within the area.

Education:

• A BS degree in Chemistry, Engineering or related field.

• 2+ years experience in FDA regulated manufacturing operations.
• Understanding and experience with pharmaceutical cGMPs, preferably those related to prefilled sterile syringe manufacturing and packaging requirements.

• Understand and apply pharmaceutical cGMPs to all aspects of work processes.
• Strong written and oral communication skills. Communicate effectively with all levels of the organization, from plant management to operations personnel.
• Excellent organizational, project, and time management skills. Able to handle change productively and other tasks as assigned.
• Strong interpersonal and communications skills to be able to work effectively in a team-based environment and to interact with global regulatory agencies.
• Strong technical knowledge and problem solving skills.
• Demonstrated ability to manage multiple priorities independently.
• Strong computer skills in a variety of software packages (Excel, JMP, Visio etc.).
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Ability to apply statistical thinking concepts to the analysis of manufacturing problems.

• Experience with CFR 820, ISO 13485
• Project management skills
• Gamma and Ethylene Oxide Sterilization experience
• Plastic mold injection experience
• Exhibits sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach
• Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes
• Ability to develop effective working relationships with team members and management with

• Experience with Adobe Illustrator

• Must be able to travel to all areas of the plant which may include walking, climbing various levels of stairs or ladders, at various floor levels in various buildings as well as the exterior of the building.
• Occasional travel: <20%