Planet Pharma · 13 hours ago
Sr Packaging Engineer
Planet Pharma is a company focused on providing expertise in packaging engineering for medical devices. They are seeking a Senior Packaging Engineer to lead validations of packaging systems, conduct gap analyses, and collaborate with stakeholders to ensure quality and regulatory compliance.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
Leads successful validations of packaging systems for medical devices
Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
Lead project meetings and provide updates to management
Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline
Minimum of 5 years in medical device or pharmaceutical industry in Packaging
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
Preferred
CAD/CAPE/TOPS Software knowledge is preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Company data provided by crunchbase