Packaging Engineer II

Primary Talent Partners, LLC; North Haven (CT); On-site; USD 69,000 - 83,000; Full time

Job summary

Primary Talent Partners is seeking a Packaging Engineer II for a medical device client in North Haven, CT. This W2 contract role focuses on designing, testing, and qualifying packaging solutions for products, ensuring compliance with GMPs.

Candidates should have 3–5 years packaging/validation experience, knowledge of IQ/OQ/PQ, DOE with Minitab preferred, and proficient in CSV, SOP development, and change control of Medical Devices.

Qualifications

• Experience in equipment IQ.
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation.
• Process Validation Lifecycle (from process characterization, operational qualification to performance qualification).
• Preferred experience in DOE (with minitab).

Responsibilities

• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required.
• Designs package exteriors considering product identification, sales appeal, aesthetic quality, printing and production techniques.
• Responsibilities may include documentation management and/or coordination of GMPs, and may support prototype line development in manufacturing facilities/plants.

Skills

IQ/OQ/PQ

DOE

Packaging experience

CSV

Education

BS Engineering

Tools

Minitab

Job description

Primary Talent Partners has a new contract opening for a Packaging Engineer II with our medical device client in North Haven, CT.

Pay: $50.00 - $60.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Description

• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
• Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Must Have

• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with minitab)

Other skills

• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices

Nice to Have

• 1-3 years of Medical Device industry experience
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS
• Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team

Top 3 technical skills that are required for the role

1. Packaging Experience
2. Validation Experience – Process Development, OQ, IQ, PQ
3. Familiarity with Cognex and Keyence based vision inspection systems

Education Required

BS (or above) Engineering Degree; Mechanical, Manufacturing, Packaging

Years' Experience Required

3-5

Primary Talent Partners is an Equal Opportunity / Aff… All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]

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