Packaging Development Engineer - Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP)
Job Title: Packaging Development Engineer - Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - (JP15071)Location: Thousand Oaks, CA. 91320Employment Type: ContractBusiness Unit: Manufacturing Science & TechnologyDuration: 1+ year (with likely extensions and/or conversion to permanent)Posting Date: 04/24/2026Pay Rate: $36-$41/W2Notes: Only qualified candidates need apply. Thousand Oaks, CA Fully Onsite - Standard Hours3 Key Consulting is hiring a Packaging Development Engineer - Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:This role is responsible for leading the development, optimization, and validation of secondary and tertiary packaging systems supporting biologics, sterile injectables, and combination products. The engineer will support packaging innovation, material selection, manufacturing readiness, and packaging performance across commercial and development programs.The position requires strong collaboration and communication skills with the ability to influence cross-functional teams including Quality, Operations, Supply Chain, Manufacturing, Regulatory, and external suppliers. The engineer will support packaging studies including transportation simulation, aging, shelf-life, environmental conditioning, packaging process studies, and supplier qualification activities.This is a highly visible role requiring a motivated engineer who brings strong problem-solving ability, continuous improvement mindset, technical curiosity, and a passion for driving robust packaging solutions.Why is the Position Open?Supplement additional workload on teamTop Must Have Skills:Ability to influence through clear and concise verbal communicationPassion for innovation and continuous improvementDemonstrated examples of self-motivation and going above and beyond minimum requirementsDay to Day Responsibilities:Package DevelopmentLead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products.Create novel designs and maintain component specifications for cartons, labels, and distribution packaging.Develop and execute packaging test protocols including:• Transportation simulation (ISTA/ASTM)• Aging and shelf-life studies• Cold-chain and environmental conditioning• Packaging manufacturing process engineering studiesEnsure compliance with global regulatory expectations (FDA, EMA, ISO, USP).Prepare and review packaging documentation for regulatory submissions.Support technology transfer, scale-up, and readiness activities at client manufacturing sites and contract manufacturing locations.Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.Partner with suppliers and Supply Chain to qualify components, assess supplier capability, manage change notifications and implement new material technologies.Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and traceability requirements.Basic Qualifications:Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.Excellent communication skills and ability to collaborate and influence across functions.Attention to detail with a mindset of getting things done correctly and robustly the first time.Ability to work onsite at client's Thousand Oaks campus.Preferred Qualifications:Master's degree in Engineering or related field.Experience with combination products, injection devices, and cold-chain distribution systems.Experience with structural design, FEA and utilization of artificial intelligence.Experience with GMP, GDP, GD&T principles.Red Flags:Long-winded, unconvincing answers to questions.Low energy.No Packaging Engineer Degrees (We're Trying Different Degrees).Interview Process:Up to 3 interviews1st round with manager2nd & 3rd rounds will be panel interviews with team members.We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you're not interested in pursuing this particular position, please feel free to review other opportunities on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone who may be interested.Regards,