Packaging Engineer

Description

The selected candidate will contribute to establishing world-class packaging solutions by providing technical expertise in the design, testing, validation, and deployment of packaging systems for both clinical and commercial applications. This position offers a unique opportunity to support innovations in packaging technologies that ensure product safety, quality, and regulatory compliance.

• Project Support: Participate in cross-functional packaging projects, supporting the delivery of innovative and compliant packaging systems.
• Change Control: Maintain global packaging solutions, support change control documentation, and perform impact assessments and requalifications.
• Collaboration: Partner with R&D, Quality, Regulatory, and Operations teams to ensure seamless packaging development and deployment.
• Material Evaluation: Evaluate and implement new or alternate packaging materials to meet regulatory, technical, and business needs.
• Compliance & Standards: Ensure packaging systems comply with GMP, GDP, FDA, ISO, ISTA, and ASTM standards.
• Continuous Improvement: Support the implementation of innovative packaging technologies under global packaging technology centers.
• Documentation & Validation: Author or co-author packaging specifications, validation protocols, and qualification reports (IQ/OQ/PQ and shipping qualifications).
• Testing & Risk Assessment: Conduct risk assessments, test protocol development, and package testing including shock, drop, vibration, tensile, and barrier analysis.
• Packaging Design & Qualification: Develop and qualify primary and secondary packaging for sterile, non-sterile, and combination products.

Requirements

Note: This is a W2-only position — No C2C or C2H candidates will be considered.

• Knowledge of packaging testing methodologies (shock, drop, vibration, peel, tensile, and barrier analysis).
• Understanding of regulatory agency requirements (FDA, MHRA, DIN, USP).
• Demonstrated problem-solving and analytical capabilities in a technical environment.
• Familiarity with sterile and non-sterile packaging systems, including vials, prefilled syringes, and device packaging.
• Experience in pharmaceutical packaging development, combination products, or medical device packaging.
• Proficiency with CAD tools (TOPS, SolidWorks), MS Office Suite, MS Project, and Adobe applications.
• Familiarity with serialization, printing systems, and global packaging material regulations.
• Ability to manage multiple priorities effectively.
• Strong attention to detail and a commitment to quality and compliance.
• Experience with design control for combination products.
• Excellent communication and collaboration abilities.
• Understanding of equipment qualification (IQ/OQ/PQ) and shipping validation requirements.
• Minimum 1 year of relevant experience in packaging engineering, preferably in the pharmaceutical or medical device industry.
• Bachelor’s degree in Packaging Engineering, Materials Science, or a related technical field required.
• Strong technical writing and documentation skills.

Benefits

Pay Rate: $37.00 - $40.02 per hour (Paid weekly, based on experience)

Benefits: Medical, Dental, Vision, and Life Insurance

Working Model: Fully onsite (5 days per week)

Training + Development

Interview process

Visa Sponsorship

Security clearance