Intellectt Inc
Job Title:
Senior Packaging Engineering Consultant
Location:
New York
Duration:
12 Months
Position Overview We are seeking a Senior Packaging Engineering Consultant to support pharmaceutical, medical device, and life sciences clients. The role involves leading packaging design, validation, equipment commissioning, and compliance projects while driving efficiency and ensuring product quality from concept to commercial launch.
Key Responsibilities
Packaging Design & Development
Develop and optimize primary and secondary packaging.
Create and review BOMs, technical specs, and CAD drawings (SolidWorks, AutoCAD, Creo).
Select and qualify materials per ISO-11607 and other standards.
Conduct line trials, packaging validation, and distribution testing per ASTM/ISTA.
Equipment & Validation
Lead procurement, installation, and validation (FAT/SAT/IQ/OQ/PQ) of packaging systems (cartoners, sealers, palletizers, etc.).
Support process validation and performance qualification in cleanroom environments.
Perform risk assessments (FMEA), CIP validation, and process capability studies.
Process Optimization & Compliance
Identify process improvements to enhance efficiency and reduce cost.
Support remediation and audit readiness for packaging and distribution compliance.
Train teams on ERP/PLM systems (SAP, Agile, Windchill, JDE).
Cold Chain & Distribution
Design and validate temperature-controlled packaging for air, sea, and ground transport.
Conduct thermal mapping, lane qualifications, and manage cold-chain testing.
Lead multi-site client projects and collaborate with QA, manufacturing, and supply chain teams.
Provide guidance on validation strategies, regulatory compliance, and audit preparation.
Qualifications
10+ years
of experience in packaging engineering (pharma, biotech, or medical device).
Strong knowledge of FDA, ISO-11607, ASTM, and ISTA standards.
Hands-on experience with automated systems and validation activities.
Proficient in CAD and PLM tools (SolidWorks, AutoCAD, SAP, Agile, Windchill).
Excellent leadership, communication, and cross-functional collaboration skills.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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Senior Packaging Engineering Consultant
Location:
New York
Duration:
12 Months
Position Overview We are seeking a Senior Packaging Engineering Consultant to support pharmaceutical, medical device, and life sciences clients. The role involves leading packaging design, validation, equipment commissioning, and compliance projects while driving efficiency and ensuring product quality from concept to commercial launch.
Key Responsibilities
Packaging Design & Development
Develop and optimize primary and secondary packaging.
Create and review BOMs, technical specs, and CAD drawings (SolidWorks, AutoCAD, Creo).
Select and qualify materials per ISO-11607 and other standards.
Conduct line trials, packaging validation, and distribution testing per ASTM/ISTA.
Equipment & Validation
Lead procurement, installation, and validation (FAT/SAT/IQ/OQ/PQ) of packaging systems (cartoners, sealers, palletizers, etc.).
Support process validation and performance qualification in cleanroom environments.
Perform risk assessments (FMEA), CIP validation, and process capability studies.
Process Optimization & Compliance
Identify process improvements to enhance efficiency and reduce cost.
Support remediation and audit readiness for packaging and distribution compliance.
Train teams on ERP/PLM systems (SAP, Agile, Windchill, JDE).
Cold Chain & Distribution
Design and validate temperature-controlled packaging for air, sea, and ground transport.
Conduct thermal mapping, lane qualifications, and manage cold-chain testing.
Lead multi-site client projects and collaborate with QA, manufacturing, and supply chain teams.
Provide guidance on validation strategies, regulatory compliance, and audit preparation.
Qualifications
10+ years
of experience in packaging engineering (pharma, biotech, or medical device).
Strong knowledge of FDA, ISO-11607, ASTM, and ISTA standards.
Hands-on experience with automated systems and validation activities.
Proficient in CAD and PLM tools (SolidWorks, AutoCAD, SAP, Agile, Windchill).
Excellent leadership, communication, and cross-functional collaboration skills.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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