What are the responsibilities and job description for the Senior Packaging Engineer position at ACL Digital?
Job Title: Senior Packaging Engineer
Location: Thousand Oaks CA
Duration: 12 Months
Description:
Location: Thousand Oaks, CA Fully Onsite
Function: Process Development / Engineering / Operations
Top 3 Must Have Skill Sets:
On-Site at ATO
Packaging Engineering Experience
Experience with Paper-Based Packaging
Responsibilities
• Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).
• Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging.
• Develop and execute packaging test protocols including:
o Transportation simulation (ISTA/ASTM)
o Aging and shelf-life studies
o Cold-chain and environmental conditioning
o Packaging line engineering studies
• Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).
• Prepare and review packaging documentation for regulatory submissions.
• Support tech transfer, scale-up, and readiness activities at Amgen manufacturing sites and CMOs.
• Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
• Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications.
• Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements.
Basic Qualifications
• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
• 7 years of packaging engineering experience in biopharmaceutical, pharmaceutical, or medical device environments.
• Strong understanding of cGMP, sterile product packaging, and biologics/combination product considerations.
• Experience with packaging validation and ISTA/ASTM distribution testing.
• Excellent communication skills and ability to collaborate across functions.
• Ability to work onsite at Amgen’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.
• Knowledge of paperboard, structural design & FEA
Enable Skills-Based Hiring No