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Engineer

Aditi Consulting

Thousand Oaks, CA

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JOB DETAILS
SALARY
$30–$37.50 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Automotive Automation, Biomedical Engineering, Biotech and Pharmaceutical, CMOS, Change Management, Chemical Engineering, Communication Skills, Consulting, 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, Messaging Technology, Product Packaging, Purchasing/Procurement, Regulatory Compliance, Regulatory Submissions, Short Messaging Service (SMS), Simulation, Speech Technology, State Laws and Regulations, Team Player, Technical Support, Telephony, Testing, Vendor/Supplier Evaluation, Vendor/Supplier Selection
LOCATION
Thousand Oaks, CA
POSTED
30+ days ago
Payrate: $30.00 - $37.50/hr.
 
Responsibilities:
  • Lead development and optimization of secondary & tertiary 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 self-life studies
    • Cold-chain and environmental conditioning
    • Packaging line engineering studies
  • Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607).
  • Prepare and review packaging documentation for regulatory submissions.
  • Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs.
  • Lead investigations into 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.
 
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
 
Must Have Skills:
  • Experience with SBS paperboard
  • Material Science Experience
  • Experience with stack up analysis
 
Pay Transparency: The typical base pay for this role across the U.S. is: $30.00 - $37.50 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy .
 
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Aditi Consulting

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