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Engineer

Calsoft Labs

Thousand Oaks, CA

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JOB DETAILS
SKILLS
Biomedical Engineering, Biotech and Pharmaceutical, CMOS, Change Management, Chemical Engineering, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Engineering, FDA Requirements, Finite Element Analysis, ISO (International Organization for Standardization), Injections, Maintain Compliance, Manufacturing, Material Science, Mechanical Engineering, Medical Equipment, Process Development, Product Packaging, Purchasing/Procurement, Regulatory Compliance, Regulatory Submissions, Simulation, Team Player, Technical Support, Testing, Vendor/Supplier Evaluation, Vendor/Supplier Selection
LOCATION
Thousand Oaks, CA
POSTED
30+ days ago
Location: Thousand Oaks, CA Fully Onsite - Standard Hours
Function: Process Development / Engineering / Operations
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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 Client 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.
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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 Client's Thousand Oaks campus.
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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

About the Company

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Calsoft Labs

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