North Haven, CT · On-site
Qualifications 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 ...
North Haven, CT · On-site
Qualifications 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 ...
Design and develop packaging systems compliant with ISO 11607-1 & 2. Author rationales, protocols, and strategies for packaging changes. Conduct and analyze packaging validation tests (seal strength ...
Quick apply
Design and develop packaging systems compliant with ISO 11607-1 & 2. Author rationales, protocols, and strategies for packaging changes. Conduct and analyze packaging validation tests (seal strength ...
San Diego, CA · On-site
$62 - $66/hr
Familiarity with IEC 60601-1, ASTM D4169, ASTM D4332, ISO 11607 * Statistical analysis experience (JMP, Minitab) * Medical device industry experience preferred Required Skills (top 3 non-negotiables)
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San Diego, CA · On-site
$62 - $66/hr
Familiarity with IEC 60601-1, ASTM D4169, ASTM D4332, ISO 11607 * Statistical analysis experience (JMP, Minitab) * Medical device industry experience preferred Required Skills (top 3 non-negotiables)
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Northfield, IL · On-site
$101K - $152K/yr
Experience conducting evaluations to meet aseptic presentation requirements per Section 7 of ISO 11607-1. * Willing to travel up to 25% of the time for business purposes (domestic and international)
Northfield, IL · On-site
$101K - $152K/yr
Experience conducting evaluations to meet aseptic presentation requirements per Section 7 of ISO 11607-1. * Willing to travel up to 25% of the time for business purposes (domestic and international)
Dekalb, IL · On-site
Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, ISO 11607, ASTM, and other applicable standards. Support packaging validation activities, including sample ...
Dekalb, IL · On-site
Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, ISO 11607, ASTM, and other applicable standards. Support packaging validation activities, including sample ...
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Quick apply
Providence, RI · On-site
Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...
Ensure compliance with ISO 11607, ISO 13485, FDA 21 CFR Part 820, EU MDR, UDI requirements and Global medical device regulations Manufacturing and Operations Support * Partner with Manufacturing ...
Ensure compliance with ISO 11607, ISO 13485, FDA 21 CFR Part 820, EU MDR, UDI requirements and Global medical device regulations Manufacturing and Operations Support * Partner with Manufacturing ...
$85 - $110/hr
Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169, etc. * Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
$85 - $110/hr
Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169, etc. * Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
Northridge, CA · On-site
Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...
Northridge, CA · On-site
Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...
Dublin, OH · On-site
$85 - $110/hr
Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169, etc. * Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
Dublin, OH · On-site
$85 - $110/hr
Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169, etc. * Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
Huntley, IL · On-site
Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, ISO 11607, ASTM, and other applicable standards. Support packaging validation activities, including sample ...
Huntley, IL · On-site
Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, ISO 11607, ASTM, and other applicable standards. Support packaging validation activities, including sample ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
Northridge, CA · On-site
Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...
Northridge, CA · On-site
Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...
$29.5K - $39.8K
5% of jobs
$39.8K - $50K
7% of jobs
$50K - $60.3K
9% of jobs
$61.8K is the 25th percentile. Wages below this are outliers.
$60.3K - $70.6K
26% of jobs
$70.6K - $80.9K
2% of jobs
The median wage is $81.6K / yr.
$80.9K - $91.1K
15% of jobs
$91.1K - $101.4K
7% of jobs
$105.9K is the 75th percentile. Wages above this are outliers.
$101.4K - $111.7K
9% of jobs
$111.7K - $122K
10% of jobs
$122K - $132.2K
6% of jobs
$132.2K - $142.5K
4% of jobs
$29.5K
$87.7K
$142.5K
| Aspect | Iso 11607 | Packaging Technician |
|---|---|---|
| Certifications | Standards for sterile packaging | Often certified in packaging processes |
| Work Environment | Manufacturing and sterile packaging facilities | Packaging lines, production areas |
| Industry Usage | Medical device and pharmaceutical packaging | Medical device, pharmaceutical, and consumer goods |
| Primary Focus | Ensuring packaging meets sterilization and safety standards | Assembling, 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.
Cities with the most Iso 11607 job openings:
States with the most job openings for Iso 11607 jobs include:
The top searched job categories for Iso 11607 jobs are:
Full-time
Posted 10 days ago
Centillion Infotech LLC has served clients since 2017 from our US headquarters in Coppell, Texas, We work with organizations across the United States the technology capability to change a system and the workforce capability to keep it running.
That combination is deliberate. Modernization programs stall when strategy, engineering and staffing sit with three parties who each own a fragment of the outcome.
Job Summary
We are seeking a Packaging Engineer with experience in Medical Device packaging, packaging equipment, and packaging validation. The ideal candidate will support packaging design, process validation, equipment qualification, and manufacturing projects while ensuring compliance with FDA and ISO standards.
Required Skills
       Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field.
       4+ years of Packaging/Manufacturing Engineering experience.
       Experience with medical packaging materials and high-volume packaging equipment (FFS, Bar Sealer, Alloyd).
       Hands-on experience with IQ, OQ, PQ and Process Validation.
       Knowledge of the Process Validation Lifecycle (Process Characterization, OQ, PQ).
       Experience preparing validation protocols, reports, SOPs, and controlled documentation.
       Strong troubleshooting, Root Cause Analysis, and project management skills.
       Experience working with cross-functional teams in Manufacturing, Quality, and Regulatory.
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 Validation (CSV).
       Medical Device Change Control.
       Custom equipment validation.
       Knowledge of FDA 21 CFR Part 820, GMP, and Medical Device Quality Systems.
Key Responsibilities
       Design and develop medical device packaging systems and manufacturing processes.
       Lead IQ, OQ, PQ, packaging validation, and equipment qualification activities.
       Develop and review validation protocols, reports, SOPs, and manufacturing documentation.
       Support packaging equipment installation, troubleshooting, and process improvements.
       Ensure compliance with FDA, ISO, GMP, and regulatory requirements.
       Manage packaging projects, timelines, and cross-functional deliverables.
       This role is ideal for a Packaging Engineer with strong experience in medical device packaging, packaging equipment, validation (IQ/OQ/PQ), ISO 11607, and project management.
Adam AB
Centillion Infotech LLC
Phone: 469.770.0087
Web:Â www.centillioninfotech.com
Email:[email protected]
