Sr Packaging Engineer

Planet Pharma; Lafayette (CO); On-site; USD 80,000 - 100,000; Full time

Job summary

Planet Pharma Group is seeking a Packaging Engineer in Lafayette, Colorado. The ideal candidate will lead efforts in successful validation of packaging systems for medical devices and conduct gap analysis in accordance with applicable standards. A Bachelor’s degree in Packaging Science or a related field and a minimum of 5 years of experience in the medical device or pharmaceutical industry is required. This position demands knowledge of ISO standards, project management skills, and team collaboration in a dynamic environment.

Qualifications

• Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
• Practical knowledge and demonstrated competence within packaging engineering typically obtained through education combined with experience.
• Knowledge of ISO 11607 part 1 and 2, ASTM and ISTA package test methods.

Responsibilities

• Evaluate current medical device product packaging design; perform gap analysis.
• Generate and execute packaging remediation plans for sterile barrier systems.
• Lead successful validation of packaging systems for medical devices.
• Identify and develop innovative packaging processes and designs.
• Utilize quality and regulatory compliance knowledge for audits and technical responses.
• Assist in labeling development process.

Skills

Packaging systems validation

Gap Analysis according to ISO11607

Project management

Quality compliance knowledge

Microsoft Office proficiency

CAD/CAPE/TOPS Software knowledge

Education

Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline

Tools

CAD/CAPE/TOPS Software

Job description

Top 3 technical skills that are required for the role:

1. Leads successful validations of packaging systems for medical devices
2. Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
3. Lead project meetings and provide updates to management

Education Required:

Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline

Years’ Experience Required:

Minimum of 5 years in medical device or pharmaceutical industry in Packaging

The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results.

Responsibilities:

• Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
• Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
• Leads successful validation of packaging systems for medical devices
• Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.
• Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
• Lead project meetings and provide updates to management.
• Assist in labeling development process.
• May perform and evaluate testing in a laboratory environment as per industry standards.

Minimum Requirements:

• Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
• Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
• Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.
• Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.
• Established and productive individual contributor with strong team and interpersonal skills.
• Knowledge of Microsoft Office programs is required.
• CAD/CAPE/TOPS Software knowledge is preferred.