Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (IST
3key Consulting, Inc., Thousand Oaks, CA, United States
Overview
Job Title: Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - JP15071
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Responsibilities
Lead 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 studies
Ensure 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.
Qualifications
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.
Interview Process
Up to 3 interviews: 1st round with manager; 2nd & 3rd rounds will be panel interviews with team members.
Application
To apply, send your resume to resumes@3keyconsulting.com. For other opportunities, visit www.3keyconsulting.com/careers.
#J-18808-Ljbffr
Job Title: Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - JP15071
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Responsibilities
Lead 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 studies
Ensure 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.
Qualifications
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.
Interview Process
Up to 3 interviews: 1st round with manager; 2nd & 3rd rounds will be panel interviews with team members.
Application
To apply, send your resume to resumes@3keyconsulting.com. For other opportunities, visit www.3keyconsulting.com/careers.
#J-18808-Ljbffr