Senior Medical Device Packaging Engineer - Validation

Planet Pharma Group; 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

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.