3 Key Consulting, Inc.

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

3 Key Consulting, Inc.  •  Thousand Oaks, CA (Onsite)  •  5 months ago
Expired
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Job Description

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.

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.


3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
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