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Iso 11607 Jobs (NOW HIRING)

Intellectt INC

Sr. Packaging Engineer

North Haven, CT · On-site

Packaging system design and validation per ISO 11607-1 & ISO 11607-2. * Knowledge of ASTM and ISTA packaging standards. * Experience with DOE (Minitab). * Computer System Validation (CSV). * Medical ...

Intellectt INC

Senior Packaging Engineer

North Haven, CT · On-site

Preferred Skills · Packaging system design and validation per ISO 11607-1 & ISO 11607-2. · Knowledge of ASTM and ISTA packaging standards. · Experience with DOE (Minitab). · Computer System ...

Intellectt INC

Packaging Engineer

Boston, MA · On-site

Support regulatory compliance efforts with FDA and ISO standards (ISO 13485, ISO 11607) * Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, and Supply Chain

Intellectt INC

Sr. Packaging Engineer

North Haven, CT · On-site

Ensure compliance with FDA, ISO 11607, and ISO 13485 requirements. Required Qualifications * Bachelor's degree in Packaging, Mechanical, Biomedical, or related Engineering discipline. * 4+ years of ...

Intellectt INC

Sr. Packaging Engineer

North Haven, CT · On-site

Ensure compliance with FDA, ISO 11607, and ISO 13485 requirements. Required Qualifications * Bachelor's degree in Packaging, Mechanical, Biomedical, or related Engineering discipline. * 4+ years of ...

Lancesoft

Sr Packaging Engineer - Exempt

Lafayette, CO · On-site

$60 - $70/hr

Validation of processes for packaging medical devices as per ISO 11607-2 * Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing ...

Intellectt INC

Sr Packaging Engineer

New Haven, CT · On-site

Design, develop, and validate packaging systems for terminally sterilized medical devices in accordance with ISO 11607-1 & ISO 11607- 2 standards * Develop and execute Installation Qualification (IQ ...

Intellectt INC

Sr Packaging Engineer

New Haven, CT · On-site

$110K - $120K/yr

Design, develop, and validate packaging systems for terminally sterilized medical devices in accordance with ISO 11607-1 & ISO 11607- 2 standards * Develop and execute Installation Qualification (IQ ...

Kelly Services

Packaging Engineer

Jacksonville, FL · On-site

Apply appropriate industry standards such as ISO 11607-2, to specify and validate packaging equipment and packaging manufacturing processes to determine appropriate sourcing, purchasing, installation ...

Intellectt INC

Packaging Engineer

North Haven, CT · On-site

ISO 11607 * Process validation * FDA 21 CFR Part 820 * GMP * Project management * Manufacturing engineering Required Qualifications * Bachelor's degree in Packaging Engineering, Mechanical ...

Intellectt INC

Sr. Packaging Engineer

North Haven, CT · On-site

FDA 21 CFR Part 820, ISO 11607 & ISO 13485 Preferred: * Sterile Barrier Systems * ASTM, ISTA & EU MDR * New Product Introduction (NPI) Education: Bachelor's degree in Packaging, Mechanical ...

Intellectt INC

Sr. Packaging Engineer

North Haven, CT · On-site

FDA 21 CFR Part 820, ISO 11607 & ISO 13485 Preferred: * Sterile Barrier Systems * ASTM, ISTA & EU MDR * New Product Introduction (NPI) Education: Bachelor's degree in Packaging, Mechanical ...

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Iso 11607 information

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$29.5K

$87.7K

$142.5K

How much do iso 11607 jobs pay per year?

As of Aug 6, 2026, the average yearly pay for iso 11607 in the United States is $87,669.00, according to ZipRecruiter salary data. Most workers in this role earn between $62,500.00 and $112,500.00 per year, depending on experience, location, and employer.

What is the difference between Iso 11607 vs Packaging Technician?

AspectIso 11607Packaging Technician
CertificationsStandards for sterile packagingOften certified in packaging processes
Work EnvironmentManufacturing and sterile packaging facilitiesPackaging lines, production areas
Industry UsageMedical device and pharmaceutical packagingMedical device, pharmaceutical, and consumer goods
Primary FocusEnsuring packaging meets sterilization and safety standardsAssembling, inspecting, and packaging products

While Iso 11607 refers to standards for sterile packaging, a Packaging Technician focuses on executing packaging processes according to those standards. The technician ensures products are properly packaged, inspected, and ready for sterilization, aligning with Iso 11607 requirements to ensure safety and compliance.

What challenges do professionals face when working with ISO 11607 compliance?

Professionals ensuring ISO 11607 compliance often face challenges in interpreting and applying the standard’s requirements to a variety of packaging materials and processes. Keeping up with evolving regulatory expectations, conducting thorough risk assessments, and validating packaging systems can be complex and time-consuming. Collaboration with cross-functional teams including R&D, quality assurance, and manufacturing is crucial to ensure that all packaging meets both regulatory and functional standards. Additionally, maintaining detailed documentation and responding to audit findings are key parts of the role.

What is ISO 11607?

ISO 11607 is an international standard that specifies requirements and test methods for packaging materials and systems used to sterilize medical devices. It ensures that packaging maintains sterility up to the point of use and provides guidance on validation processes. The standard is divided into two parts: Part 1 covers requirements for materials and design, while Part 2 focuses on packaging process validation. Compliance with ISO 11607 is critical for manufacturers to ensure patient safety and meet regulatory requirements.

What skills and qualifications are needed to work with ISO 11607?

To thrive as an ISO 11607 Compliance Specialist, you need expertise in packaging validation, regulatory standards for sterile medical devices, and a background in engineering, quality assurance, or a related scientific field. Familiarity with technical tools such as validation protocols, statistical analysis software, and document control systems is typically required, as well as knowledge of ISO 11607-1 and ISO 11607-2 standards. Strong attention to detail, analytical thinking, and effective communication help ensure compliance and successful collaboration with cross-functional teams. These skills ensure that medical device packaging meets regulatory requirements, safeguarding patient safety and supporting product quality.
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Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in the United States as of August 2026, with employment types broken down into 90% Full Time, 2% Part Time, 6% Contract, and 2% Nights. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $87,669 per year, or $42.1 per hour.

Senior Packaging Engineer

Intellectt INC

North Haven, CT • On-site

Other

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Job Description

We are seeking an experienced Packaging Validation Engineer to support the design, development, validation, and continuous improvement of packaging systems for terminally sterilized medical devices. The ideal candidate will have strong expertise in medical device packaging, equipment qualification, process validation, and regulatory compliance while collaborating with cross-functional teams to ensure high-quality, compliant manufacturing processes.

Key Skills

  • Medical packaging materials and packaging equipment (FFS, Bar Sealer, Alloyd)
  • Packaging system design and development per ISO 11607-1
  • Process validation including IQ, OQ, PQ and Process Validation Lifecycle
  • Equipment qualification and validation documentation
  • ASTM and ISTA packaging standards
  • FDA 21 CFR Part 820 Quality System Regulations and Medical Device GMP
  • Manufacturing process development and statistical process control
  • Project management, project planning, and execution
  • Manufacturing documentation, SOP development, and change control
  • Cross-functional collaboration with Manufacturing, Quality, Regulatory, and Engineering

Required Qualifications

  • Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related Engineering discipline
  • Experience with medical device packaging validation and terminally sterilized products
  • Strong knowledge of ISO 11607-1 and ISO 11607-2 requirements
  • Experience performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Experience developing and reviewing validation protocols, reports, and controlled documentation
  • Knowledge of manufacturing process design, equipment qualification, and failure analysis
  • Experience leading projects, timelines, and technical deliverables

Additional Skills

  • DOE (Design of Experiments) using Minitab
  • Computer System Validation (CSV)
  • Custom equipment validation
  • SOP development
  • Medical device change control
  • Statistical Process Control (SPC)
  • Documentation management and GMP compliance
  • Strong communication and stakeholder management skills

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