Ensure compliance with applicable international regulations, standards, and industry requirements. * Support technical problem-solving and troubleshooting efforts across sterilization-related ...
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CIS International
22 jobs near Columbus, OH
Ensure compliance with applicable international regulations, standards, and industry requirements. * Support technical problem-solving and troubleshooting efforts across sterilization-related ...
Summary: Responsible for coordinating projects, inventory activities, and operational initiatives to support business continuity and manufacturing operations. The Project Coordinator collaborates ...
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Summary: Responsible for coordinating projects, inventory activities, and operational initiatives to support business continuity and manufacturing operations. The Project Coordinator collaborates ...
$89K - $122K/yr
SUMMARY: To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or ...
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$89K - $122K/yr
SUMMARY: To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or ...
Summary: The Product Development Engineer supports the design, development, and continuous improvement of medical device products by implementing engineering changes, maintaining design documentation ...
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Summary: The Product Development Engineer supports the design, development, and continuous improvement of medical device products by implementing engineering changes, maintaining design documentation ...
Sr. Quality Application Specialist (Science)/ Sr. Quality Engineer (Engineer)
Juncos, PR · On-site
$86K - $116K/yr
Key Requirements: * Bachelor's degree in Engineering or Science. * Knowledge and experience with IT systems and integrations with manufacturing equipment. * Minimum of 4 years of experience in ...
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Sr. Quality Application Specialist (Science)/ Sr. Quality Engineer (Engineer)
Juncos, PR · On-site
$86K - $116K/yr
Key Requirements: * Bachelor's degree in Engineering or Science. * Knowledge and experience with IT systems and integrations with manufacturing equipment. * Minimum of 4 years of experience in ...
PR · On-site
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
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PR · On-site
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
$101K - $131K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
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$101K - $131K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
PR · On-site
SUMMARY: To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
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PR · On-site
SUMMARY: To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
$89K - $122K/yr
SUMMARY: To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or ...
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$89K - $122K/yr
SUMMARY: To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or ...
Summary We are seeking a detail-oriented Purchasing Agent with experience in procurement, supplier coordination, and invoice discrepancy resolution within a fast-paced environment. The ideal ...
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Summary We are seeking a detail-oriented Purchasing Agent with experience in procurement, supplier coordination, and invoice discrepancy resolution within a fast-paced environment. The ideal ...
PR · On-site
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
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PR · On-site
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
PR · On-site
Summary: The Capital Engineering Department of a pharmaceutical manufacturing company is responsible for planning and executing capital projects that support manufacturing, packaging, laboratories ...
New
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PR · On-site
Summary: The Capital Engineering Department of a pharmaceutical manufacturing company is responsible for planning and executing capital projects that support manufacturing, packaging, laboratories ...
New
Sr. EHS Specialist
Juncos, PR · On-site
SUMMARY: * Support manufacturing operations and EHS team to ensure full compliance with Environmental, Health & Safety (EHS) programs. * Conduct EHS training and onboarding for new hires, including ...
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Sr. EHS Specialist
Juncos, PR · On-site
SUMMARY: * Support manufacturing operations and EHS team to ensure full compliance with Environmental, Health & Safety (EHS) programs. * Conduct EHS training and onboarding for new hires, including ...
PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
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PR · On-site
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
Summary: Seeking a competent junior-to-mid-level Commissioning Qualification and Validation Specialist (CQV) to support upcoming Qualification and Validation activities. This contractor will play a ...
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Summary: Seeking a competent junior-to-mid-level Commissioning Qualification and Validation Specialist (CQV) to support upcoming Qualification and Validation activities. This contractor will play a ...
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
Quick apply
$102K - $140K/yr
SUMMARY: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or ...
PR · On-site
SUMMARY: Under limited supervision, execute advanced maintenance activities or operate assigned equipment, facility, utility, and HVAC Systems in accordance with established guidelines and operating ...
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PR · On-site
SUMMARY: Under limited supervision, execute advanced maintenance activities or operate assigned equipment, facility, utility, and HVAC Systems in accordance with established guidelines and operating ...
SUMMARY: Quality Application Specialist to support product transfer, process validation, and commercialization activities within a regulated medical device manufacturing environment. The selected ...
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SUMMARY: Quality Application Specialist to support product transfer, process validation, and commercialization activities within a regulated medical device manufacturing environment. The selected ...
SUMMARY: Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. FUNCTIONS: * Review and approve product MPs.
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SUMMARY: Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. FUNCTIONS: * Review and approve product MPs.
Summary: Serve as a strategic liaison between the Capital Projects department and the Facilities team, coordinating space planning, personnel movements, and material relocation to ensure operational ...
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Summary: Serve as a strategic liaison between the Capital Projects department and the Facilities team, coordinating space planning, personnel movements, and material relocation to ensure operational ...
Sterilization Program Manager- Ethylene Oxide (EO) (Remote Work)
Juncos, PR • On-site, Remote
Full-time
Posted 3 days ago
Job description
Summary:
The Sterilization Program Manager is responsible for leading and managing the sterilization project portfolio, including new product launches, validation and revalidation activities, process improvements, and operational support. This role provides technical oversight for Ethylene Oxide (EO) sterilization processes, drives cross-functional collaboration, manages supplier relationships, and ensures compliance with global sterilization regulations and standards.
Key Responsibilities:
Program & Portfolio Management
Sterilization & Validation
The Sterilization Program Manager is responsible for leading and managing the sterilization project portfolio, including new product launches, validation and revalidation activities, process improvements, and operational support. This role provides technical oversight for Ethylene Oxide (EO) sterilization processes, drives cross-functional collaboration, manages supplier relationships, and ensures compliance with global sterilization regulations and standards.
Key Responsibilities:
Program & Portfolio Management
- Lead and manage the full sterilization project portfolio, including:
- New product launches
- Sterilization validations and revalidations
- Process improvement initiatives
- Develop and maintain integrated project plans, timelines, resource allocation plans, and risk registers.
- Drive alignment across cross-functional teams including R&D, Quality, Regulatory Affairs, Operations, and Supply Chain.
- Facilitate portfolio prioritization and support trade-off decisions with senior leadership.
- Establish, monitor, and report key performance indicators (KPIs), project milestones, and program health metrics.
- Serve as Subject Matter Expert (SME) for EO sterilization processes.
- Provide technical guidance related to microbiological and chemical sterilization methods.
- Ensure compliance with applicable international regulations, standards, and industry requirements.
- Support technical problem-solving and troubleshooting efforts across sterilization-related activities.
- Collaborate with internal SMEs to resolve complex sterilization challenges.
- Coordinate with internal stakeholders to manage relationships with contract sterilization providers and laboratory service vendors.
- Support project scheduling and resource planning with external service suppliers.
- Ensure supplier activities align with project priorities, timelines, and business objectives.
- Communicate project status, risks, mitigation plans, and key decisions to executive leadership and cross-functional teams.
- Lead change control activities associated with sterilization process modifications.
- Promote continuous improvement initiatives and process optimization opportunities.
- Drive effective stakeholder engagement throughout the project lifecycle.
- Bachelor’s Degree in:
- Biomedical Engineering
- Chemical Engineering
- Microbiology or related scientific/engineering discipline
- Minimum 3 years of experience in EO sterilization validation and/or sterilization operations.
- Strong knowledge of sterilization validation lifecycle activities.
- Experience supporting validation, compliance, and process improvement projects.
- PMP Certification or equivalent project management certification.
- Experience in medical device, pharmaceutical, or regulated manufacturing environments.
- Knowledge of international sterilization standards and regulatory requirements.
Sterilization & Validation
- EO Sterilization Processes
- Sterilization Validation Lifecycle
- Revalidation Activities
- Microbiological Methods
- Chemical Sterilization Methods
- Regulatory Compliance
- Portfolio Management
- Resource Planning
- Project Scheduling
- Risk Management
- FMEA
- Risk Registers
- KPI Development & Reporting
- Cross-Functional Leadership
- Microsoft Office Suite
- Microsoft Project
- Smartsheet
- Agile Methodologies
- Leadership
- Strategic Planning
- Stakeholder Management
- Communication & Presentation Skills
- Problem Solving
- Continuous Improvement Mindset
- Change Management
- Remote work reporting to the Juncos, PR site.
- Full Time Job
- Shift: Administrative Shift, but needs to be available for others.
- Duration: 1 year (with possible extension or conversion depending on project and performance).
- Professional services Contract
- Type of industry: Medical devices
About CIS International
Sourced by ZipRecruiter
Company size
11 - 50 Employees
Headquarters location
Gardena, CA, US
Year founded
1991