We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final ...
72 Katalyst Process Engineer Jobs Hiring Near You
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final ...
C&Q Engineer
New Albany, OH · On-site
Apply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect ... Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of ...
C&Q Engineer
New Albany, OH · On-site
Apply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect ... Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of ...
Engineer Level 2
Raymond, OH · On-site
Requires a BS or MS in engineering. * All the skills and abilities of Engineer L1. * Additionally, must be proficient in technical writing and possess computer skills for scientific and technical ...
Engineer Level 2
Raymond, OH · On-site
Requires a BS or MS in engineering. * All the skills and abilities of Engineer L1. * Additionally, must be proficient in technical writing and possess computer skills for scientific and technical ...
Senior Validation Engineer
Columbus, OH · On-site
We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support ... processes. The ideal candidate will have strong experience authoring, reviewing, and executing CQV ...
Senior Validation Engineer
Columbus, OH · On-site
We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support ... processes. The ideal candidate will have strong experience authoring, reviewing, and executing CQV ...
CSV Engineer
Columbus, OH · On-site
The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). * This role ...
CSV Engineer
Columbus, OH · On-site
The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). * This role ...
Senior Validation Engineer
Blacklick, OH · On-site
Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define ... Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical ...
Senior Validation Engineer
Blacklick, OH · On-site
Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define ... Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical ...
A Software Engineer who works within a development team to lead the development of infotainment software with a focus on headunit software, creating a top-class infotainment platform that applied to ...
A Software Engineer who works within a development team to lead the development of infotainment software with a focus on headunit software, creating a top-class infotainment platform that applied to ...
Design Engineer L2
Raymond, OH · Hybrid
Qualification: * BS/MS in Mechanical Engineering.
Design Engineer L2
Raymond, OH · Hybrid
Qualification: * BS/MS in Mechanical Engineering.
Analyzes engineering drawings, and specifications to determine shape, dimensions, hardness etc. in the development of equipment, processes, and products. * Examine feasibility of using one or more ...
Analyzes engineering drawings, and specifications to determine shape, dimensions, hardness etc. in the development of equipment, processes, and products. * Examine feasibility of using one or more ...
Quality Manager
Alexandria, OH · On-site
This role focuses on aligning stakeholders, evaluating current quality processes and systems, and ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...
Quality Manager
Alexandria, OH · On-site
This role focuses on aligning stakeholders, evaluating current quality processes and systems, and ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...
Process purchase requisitions and generate purchase orders accurately and timely. * Coordinate with suppliers to ensure on-time delivery of materials and services. * Monitor inventory levels and ...
Process purchase requisitions and generate purchase orders accurately and timely. * Coordinate with suppliers to ensure on-time delivery of materials and services. * Monitor inventory levels and ...
GIS Specialist
Columbus, OH · On-site
Required Qualifications : * Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every ...
GIS Specialist
Columbus, OH · On-site
Required Qualifications : * Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every ...
Process Engineer III
Portsmouth, NH · On-site
Katalyst CRO is a company focused on providing comprehensive infrastructure services. They are seeking a Process Engineer III to plan, design, and support IT infrastructure services, particularly in ...
Process Engineer III
Portsmouth, NH · On-site
Katalyst CRO is a company focused on providing comprehensive infrastructure services. They are seeking a Process Engineer III to plan, design, and support IT infrastructure services, particularly in ...
The Process Engineer II supports manufacturing operations by optimizing production processes, implementing process improvements, and ensuring compliance with quality and regulatory standards. This ...
The Process Engineer II supports manufacturing operations by optimizing production processes, implementing process improvements, and ensuring compliance with quality and regulatory standards. This ...
CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization ...
CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization ...
Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge ...
Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge ...
Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge ...
Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge ...
Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge ...
Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge ...
CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization ...
CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization ...
CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization ...
CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization ...
Katalyst Jobs Information
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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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Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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Sr Engineer- Process Development (CQV)
Newark, OH • On-site
Katalyst
Full-time
Re-posted 14 days ago
Job description
Job Summary:
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams.
Roles & Responsibilities:- Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes.
- Author, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Maintain and manage Master Validation Plans and related documentation to ensure compliance with GMP and FDA regulations.
- Serve as the technical SME for automated systems, labeling, and packaging process validation.
- Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure robust and validated systems supporting 24/7 production operations.
- Conduct on-site and off-shift validation activities as needed to support continuous manufacturing operations.
- Identify process gaps and recommend improvements to optimize validation and operational efficiency.
- Support regulatory audits and inspections by providing accurate and complete validation documentation.
- Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field.
- Proven experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated manufacturing environment.
- Hands-on experience with automated and semi-automated equipment, labeling, and packaging operations.
- Strong knowledge of FDA regulations, GMP standards, and internal quality systems.
- Experience with validation documentation including Master Validation Plans, IQ/OQ/PQ protocols, and reports.
- Familiarity with Kneat software is a plus.
- Ability to work flexible schedules, including on-site and off-shift validation activities.