About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the role
The Packaging Lab Technician II supports the development, testing, and validation of medical device packaging systems to ensure product safety, sterility, and regulatory compliance. This role performs hands-on laboratory testing, supports packaging validations, maintains lab equipment, and assists with documentation in accordance with FDA, ISO, and internal quality standards.
What you'll do
· Perform package integrity testing (dye penetration, bubble leak, burst, peel, seal strength)
· Support packaging validation activities (IQ/OQ/PQ)
· Execute packaging performance testing per ASTM, ISTA, and ISO standards
· Support transportation simulation testing (vibration, compression, drop)
· Prepare test samples, fixtures, and materials per protocols
· Maintain accurate test records, data logs, and reports
· Assist in protocol execution and report generation
· Ensure compliance with ISO 11607, FDA QSR (21 CFR Part 820), and internal procedures
· Support change control, deviations, and CAPAs related to packaging
· Operate and maintain packaging test equipment
· Perform routine equipment checks and calibrations
· Maintain lab cleanliness and 5S standards
· Identify equipment issues and escalate as needed
· Work closely with Packaging Engineers, Quality, Manufacturing, and R&D
· Support packaging design evaluations and material selection
· Assist with supplier testing and incoming material evaluations
What you will bring
· Associate’s or Technical degree in Packaging Science, Engineering, Biology, Chemistry, or related field
· 2+ years of experience in a packaging, laboratory, or medical device environment
· Hands-on experience with package integrity testing methods
· Familiarity with ISO 11607, ASTM, and FDA QSR requirements
· Strong attention to detail and documentation accuracy
· Familiarity with statistical analysis tools
· Ability to follow test protocols precisely
· Excellent documentation skills
· Strong communication and teamwork abilities
· Ability to manage multiple tasks in a lab environment
Working Conditions and Physical Effort
· Position may include exposure to loud noises from machines and or alarms.
· Position may require from time to time, physical work; heavy lifting, pushing, or pulling required of objects up to 20-25 pounds.
· Work environment may involve some exposure to hazards or physical risks, which will require following basic safety precautions.
· Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, and/or unpleasant odors
· All required personal protective equipment (PPE) will be provided to ensure a safe working environment.
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.