ACL Digital · 1 month ago
Senior Packaging Engineer
Thousand Oaks, CA
Contract
Onsite
Senior Level
7+ years expACL Digital is seeking a Senior Packaging Engineer to join their team in Thousand Oaks, CA. The role focuses on developing and optimizing packaging for biologics and sterile injectables while ensuring compliance with regulatory standards.
Business IntelligenceCloud ComputingDevOpsHardwareInformation TechnologyInternet of ThingsMobile AppsRetail TechnologySaaSSoftware
Hiring Manager
Chiranjeevi Mittkella
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:
Transportation simulation (ISTA/ASTM)
Aging and shelf-life studies
Cold-chain and environmental conditioning
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
Qualification
Required
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
On-Site at ATO
Packaging Engineering Experience
Experience with Paper-Based Packaging
Preferred
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
Company
ACL Digital
ACL Digital is a design-led digital engineering and transformation firm.
1001-5000 employees
H1B Sponsorship
ACL Digital has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (29)
2023 (26)
2022 (33)
2021 (20)
2020 (19)
Funding
Current Stage
Late StageLeadership Team
Srikanth Raghavan
Associate Vice President
Recent News
2025-11-28
Precedence Research
2025-11-28
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