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Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
Location: Thousand Oaks, CA. 91320
Employment Type:  Contract
Business Unit: Manufacturing Science & Technology

Function: Process Development / Engineering / Operations
Duration: 12 months with likely extension or conversion to permanent
Rate: $48-52 on W2 with Benefits
Posting Date:  11/28/2025

3 Key Consulting is hiring a Senior Packaging Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description / 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 Company’s 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.

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

Why is the Position Open?
Supplement additional workload on team

Top Must-Have Skill Sets:
  • On-Site
  • Packaging Engineering Experience
  • Experience with Paper-Based Packaging

Day to Day 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 company’s 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.

Employee Value Proposition:
Unique industry opportunity and experience.

Red Flags:
  • Gaps in employment
  • Currently resides more than 100 miles away
  • Multiple jobs held for less than one year

Interview process:
Two interviews, possibly three - video conference

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.


 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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