Packaging Engineer
Actalent
Remote
$114,400 Salary, Full-Time
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Job Description
- will deliver both remote and onsite support to evaluate and advance secondary packaging solutions for NextGen cytokines and CGT products, ensuring alignment with regulatory expectations, sustainability goals, variable product volumes, and future packing automation.
Duties and Responsibilities:
- Evaluate potential packaging materials to align both client and regulatory requirements (ie. USP, EP, ISO11607, ISO13485, EPR, PPWR, etc.)
- Evaluate packaging materials (secondary packaging materials/clean room sleeve) that protect closed-process systems against mechanical stress and cold storage
- Identify and develop a range of packaging sizes to meet the needs of the clients' customers
- Identify and recommend testing methods to support design verification and validation, materials evaluation, vendor qualification, and packaging validation.
- Make recommendations for automated secondary packaging solutions to scale as needed
- Process optimization focused on making recommendations to improve packaging line efficiency, reduce scrap, and enhance robustness, increase sustainability etc. Required Capabilities (How will we measure fit?):
- Must have strong hands on understanding of aseptic packaging, sterile barrier systems, and materials
- Ability to evaluate different materials, sizes, volumes, and packaging systems at a variety of mechanical stresses and temperatures (ie ambient,
- 80C)
- Skilled in materials science, mechanical properties, barrier performance, and failure mechanisms
- Able to create and recommend testing protocols consistent with industry standards
- Able to design and troubleshoot IOPQ protocols, transit simulations, and cryogenic stress tests
- Comfortable navigating regulatory documentation including, but not limited to: USP, EP, ISO11607, ISO13485, EPR, PPWR, and other global packaging standards
- Skilled in FMEA, hazard analysis, and root‑cause investigations
- Able to evaluate supplier data, challenge assumptions, and qualify new materials or components
- Familiar with thermal modeling, shipper qualification, and temperature‑excursion mitigation
- Must have strong documentation and communication skills
- Must have a safety and compliance oriented mindset Skills Packaging engineering, medical device, vendor management, Packaging, Packaging design, Solidworks, Supply chain, materials management, materials logistics, pharmaceutical industry, Project management, temperature controls, regulatory compliance, gmp environment Top Skills Details Packaging engineering,medical device,vendor management
Additional Skills & Qualifications Qualifications:
- BS, Master's, or PhD degree in Packaging Engineering, Materials Science, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field.
- 5-10 years of experience in in packaging engineering, ideally in biologics, cell therapy, gene therapy, or sterile pharmaceuticals
- Experience with aseptic fill-finish operations, cryogenic storage systems, and packaging validation
- Experience with regulatory documentation including, but not limited to: USP, EP, ISO11607, ISO13485, EPR, and PPWR
- (Preferred) experience with global regaulatory submissions Experience Level Intermediate Level Job Type & Location This is a Contract position based out of Minneapolis, MN. Pay and Benefits The pay range for this position is $52.00
- $58.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position.
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