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Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
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:
Preferred Qualifications:
Why is the Position Open?
Supplement additional workload on team
Top Must-Have Skill Sets:
Day to Day Responsibilities
Employee Value Proposition:
Unique industry opportunity and experience.
Red Flags:
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.
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.