Job Summary: * The Packaging Validation Engineer will be responsible for supporting and executing packaging validation activities to ensure packaging integrity, compliance, and product quality.
8 Katalyst Jobs Hiring in Bloomington, IN
Job Summary: * The Packaging Validation Engineer will be responsible for supporting and executing packaging validation activities to ensure packaging integrity, compliance, and product quality.
Job Summary: * Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements. * Lead or support complaint investigations and resolution related to ...
Job Summary: * Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements. * Lead or support complaint investigations and resolution related to ...
Responsibilities: * Lead migration of legacy documents into Kneat digital platform, ensuring compliance and consistency. * Qualify redundant lab equipment (e.g., pH meters, thermal mixers ...
Responsibilities: * Lead migration of legacy documents into Kneat digital platform, ensuring compliance and consistency. * Qualify redundant lab equipment (e.g., pH meters, thermal mixers ...
Job Summary: * The Packaging Validation Engineer is responsible for executing and supporting packaging validation activities to ensure packaging systems meet regulatory, quality, and internal ...
Job Summary: * The Packaging Validation Engineer is responsible for executing and supporting packaging validation activities to ensure packaging systems meet regulatory, quality, and internal ...
Summary: * Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements. * Hands-on experience in Process validation (IQ, OQ & PQ) activities. * Lead ...
Summary: * Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements. * Hands-on experience in Process validation (IQ, OQ & PQ) activities. * Lead ...
Objectives: * Design- Support global facilities during all engineering phases. * Ensuring project meets requirements. * Delivery- Support automation for new manufacturing sites. * Project leadership.
Objectives: * Design- Support global facilities during all engineering phases. * Ensuring project meets requirements. * Delivery- Support automation for new manufacturing sites. * Project leadership.
Summary : The CSV Specialist will plan, execute, and document validation activities for GxP-regulated computerized systems. This role supports system lifecycle activities, audits, and compliance ...
Summary : The CSV Specialist will plan, execute, and document validation activities for GxP-regulated computerized systems. This role supports system lifecycle activities, audits, and compliance ...
Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant ...
Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
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Job description
Job Summary:
- The Packaging Validation Engineer will be responsible for supporting and executing packaging validation activities to ensure packaging integrity, compliance, and product quality.
- This role works closely with Quality, Engineering, Manufacturing, and Regulatory teams and supports validation, change management, and continuous improvement initiatives in an onsite manufacturing environment.
- Perform hands-on packaging validation activities, including packaging integrity, shelf-life, and transit testing
- Prepare packaging verification/validation protocols and reports in compliance with regulatory and internal requirements
- Execute and support Process Validation activities including IQ, OQ, and PQ
- Lead or support complaint investigations and resolutions related to packaging
- Support engineering with product validation, risk assessments, product/process development, and change management
- Support and lead continuous improvement activities through collaboration and facilitation
- Ensure all packaging validation activities are properly documented and controlled
- Collaborate with QA, Engineering, Manufacturing, Regulatory, and Supply Chain teams to ensure compliance
- Communicate packaging validation status and issues effectively across departments
- Create and manage Engineering Change Orders (ECOs) using Agile
- 4-6 years of recent experience in Packaging Validation
- Strong knowledge of Good Documentation Practices
- Good verbal and written communication skills
- Working knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
- Experience working in a regulated manufacturing environment