CONTRACT ROLE: Packaging Engineer

SaniSure LLC•Camarillo, CA

10d•$60 - $70

About The Position

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry. The Packaging Engineer works closely with Product Line Management, R&D, Operations, Manufacturing Engineering, Quality, Regulatory, and Supply Chain on primary and secondary packaging developments and improvements. Scope includes project management and technical leadership for packaging and labeling design during New Product Introductions and post-launch improvements, and driving and facilitating associated portions of product and process change management related to packaging, including deviation and non-conformance resolution.

Requirements

Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Science, Industrial Engineering, or related field.
4-6+ years hands-on packaging and/or labeling design and development experience within the pharmaceutical, biotech, or medical device industry, or related regulated industry.
Strong understanding of materials commonly used in pharmaceutical or medical device packaging, including the structural and chemical properties of glass, polymers, adhesives, inks, varnishes, and paper.
Working knowledge of industry packaging testing standards (ISTA, ASTM, TAPPI).
Proficiency with CAD software (e.g., SolidWorks) for packaging design.
Design verification and process verification/validation protocol and report writing.
Design control, change control, and risk management experience (DFMEA, PFMEA).
Project management and strong organizational and time management skills with high sense of urgency. Detail and deadline oriented.
High initiative with the ability to work independently and problem solve with minimal supervision or direction.
Must have a strong work ethic and ability to communicate effectively, both verbally and in writing. Strong interpersonal skills: ability to interact with staff at all levels within and external to the organization.
Experience working in a GMP (Good Manufacturing Practice) environment; familiarity with GDP (Good Distribution Practice) and Quality management systems a plus.
Ability and willingness to travel up to 10%, including occasional international for supplier visits.

Nice To Haves

Sustainable packaging design and lifecycle assessment experience
Familiarity with automated packaging/filling line equipment
Six Sigma / Lean certification

Responsibilities

Develop clear primary and secondary packaging requirements by gathering voice of customer through Sales and Product Line Managers, reviewing historical customer complaint and non-conformance data to identify common issues with existing packaging, and comparing SaniSure packaging designs with competitors and adjacent industry best practices.
Analyze packaging specifications, designs, including technical drawings and Bills of Materials (BOMs).
Provide engineering support for packaging compliance (GMP, GDP, sustainability regulations, REACH, RoHS, and other applicable regulatory or customer requirements).
Design and develop primary, secondary, and tertiary packaging and labeling for new and existing products, ensuring product protection and usability.
Evaluate and select packaging materials (polymers, adhesives, inks, varnishes, paper, corrugate, films, foams, sustainable alternatives) based on cost, performance, regulatory suitability, and environmental impact.
Work with vendors and suppliers to optimize packaging and labeling solutions, coordinate material procurement, and provide testing oversight. Create supplier and component redundancy and resolve supplier issues.
Work with Design Engineering and Manufacturing to integrate a Design for Manufacture & Assembly and Design to Cost perspective into packaging designs.
Develop testing strategies and protocol documentation.
Plan and conduct package and label verification and validation testing, including ISTA and ASTM protocols; drop, vibration, compression, humidity, and temperature-controlled. Generate test reports summarizing results.
Drive Capital equipment requests and qualification for packaging lines and equipment.
Support driving full documentation of packaging design including BOM, drawings, change control, and procedures.
Lead risk assessment activities including Design Failure Mode Effects Analysis (DFMEA) for packaging designs.
Partner with Quality and Operations to support design verification and process validation activities for packaging systems and labeling.
Provide technical support during manufacturing transitions and troubleshoot manufacturing and packaging-related issues.
Support deviation and non-conformance activities related to packaging issues and drive effective corrective actions.
Support customer complaint investigations related to packaging and analyze complaint data to identify and address systemic design issues. Propose design changes to resolve. Act with a sense of urgency to manage implementation and monitor effectiveness.
Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute packaging improvements and enhancements.
Perform other duties as assigned.