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 ...
64 Katalyst Product Manufacturing Jobs Hiring Near You
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 ...
... product. * This is not a validation role - we are looking for a true C&Q professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a ...
... product. * This is not a validation role - we are looking for a true C&Q professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a ...
Mechanical Tool Designer
Delaware, OH · On-site
... and products. * Examine feasibility of using one or more machines to carry out sequential ... Design and develop manufacturing automation systems, including assembly automation, machine ...
Mechanical Tool Designer
Delaware, OH · On-site
... and products. * Examine feasibility of using one or more machines to carry out sequential ... Design and develop manufacturing automation systems, including assembly automation, machine ...
... manufacturing operations by leading validation activities for key systems, including Veeva QMS ... ensuring product quality, patient safety, and regulatory inspection readiness. Roles ...
... manufacturing operations by leading validation activities for key systems, including Veeva QMS ... ensuring product quality, patient safety, and regulatory inspection readiness. Roles ...
Manufacturing Engineer I
Broomfield, CO · On-site
$73K - $94K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Own production planning and sequencing for spacecraft, payload, and subsystem builds; coordinate ...
Manufacturing Engineer I
Broomfield, CO · On-site
$73K - $94K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Own production planning and sequencing for spacecraft, payload, and subsystem builds; coordinate ...
Manufacturing Engineer I
$70K - $110K/yr
Own production planning and sequencing for spacecraft, payload, and subsystem builds; coordinate ... At Katalyst our work on projects involving the U.S. Department of Defense requires adherence to ...
Manufacturing Engineer I
$70K - $110K/yr
Own production planning and sequencing for spacecraft, payload, and subsystem builds; coordinate ... At Katalyst our work on projects involving the U.S. Department of Defense requires adherence to ...
Supply Chain Manager
$105K - $135K/yr
Support the execution of Katalyst's end-to-end supply chain operations, helping ensure the timely ... and production. * Build and manage relationships with suppliers, manufacturers, and strategic ...
Supply Chain Manager
$105K - $135K/yr
Support the execution of Katalyst's end-to-end supply chain operations, helping ensure the timely ... and production. * Build and manage relationships with suppliers, manufacturers, and strategic ...
Supply Chain Manager
Broomfield, CO · On-site
$105K - $135K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... and production. * Build and manage relationships with suppliers, manufacturers, and strategic ...
Supply Chain Manager
Broomfield, CO · On-site
$105K - $135K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... and production. * Build and manage relationships with suppliers, manufacturers, and strategic ...
Quality Engineer
Broomfield, CO · On-site
$110K - $145K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead process improvement initiatives to reduce defects, improve yield, and increase production ...
Quality Engineer
Broomfield, CO · On-site
$110K - $145K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead process improvement initiatives to reduce defects, improve yield, and increase production ...
Quality Engineer
$110K - $145K/yr
Provide management system training and guidance to Katalyst internal stakeholders to build ... Lead process improvement initiatives to reduce defects, improve yield, and increase production ...
Quality Engineer
$110K - $145K/yr
Provide management system training and guidance to Katalyst internal stakeholders to build ... Lead process improvement initiatives to reduce defects, improve yield, and increase production ...
Mechanical Engineer II, Structures & Layout
Broomfield, CO · On-site
$110K - $140K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Partner closely with manufacturing and technicians to support prototype and flight builds, resolve ...
Mechanical Engineer II, Structures & Layout
Broomfield, CO · On-site
$110K - $140K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Partner closely with manufacturing and technicians to support prototype and flight builds, resolve ...
Mechanical Engineer II, Structures & Layout
Broomfield, CO · On-site
$110K - $140K/yr
Partner closely with manufacturing and technicians to support prototype and flight builds, resolve ... At Katalyst our work on projects involving the U.S. Department of Defense requires adherence to ...
Mechanical Engineer II, Structures & Layout
Broomfield, CO · On-site
$110K - $140K/yr
Partner closely with manufacturing and technicians to support prototype and flight builds, resolve ... At Katalyst our work on projects involving the U.S. Department of Defense requires adherence to ...
Manufacturing Engineer
Greenville, SC · On-site
$68K - $88K/yr
The Manufacturing Engineer supports production operations by developing and improving manufacturing processes to enhance product quality, efficiency, and safety. This role works closely with ...
Manufacturing Engineer
Greenville, SC · On-site
$68K - $88K/yr
The Manufacturing Engineer supports production operations by developing and improving manufacturing processes to enhance product quality, efficiency, and safety. This role works closely with ...
Sterile drug product manufacturing. * GMP pharma process validation. * Experience working with CMOs. * Ability to travel (domestic and/or international). Key Stakeholders: * Manufacturing. * Quality.
Sterile drug product manufacturing. * GMP pharma process validation. * Experience working with CMOs. * Ability to travel (domestic and/or international). Key Stakeholders: * Manufacturing. * Quality.
Vice President of Engineering
Broomfield, CO · On-site
$181K - $233K/yr
Partner closely with Program, Product, Operations, Manufacturing, Supply Chain, Quality, Finance ... Katalyst's bias toward hands-on ownership and speed. * Build the engineering talent system ...
Vice President of Engineering
Broomfield, CO · On-site
$181K - $233K/yr
Partner closely with Program, Product, Operations, Manufacturing, Supply Chain, Quality, Finance ... Katalyst's bias toward hands-on ownership and speed. * Build the engineering talent system ...
MES Engineer
Grand Forks, ND · On-site
The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product ...
MES Engineer
Grand Forks, ND · On-site
The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product ...
Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are ...
Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are ...
MES Engineer
Phoenix, AZ · On-site
The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product ...
MES Engineer
Phoenix, AZ · On-site
The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product ...
2027 University New Hire-Lubricants
$95K - $102K/yr
Our products reach across automotive, trucking, agriculture, aviation, power generation, mining ... KATALYST associates experience a brief but dynamic immersion to the Phillips 66 energy value chain ...
2027 University New Hire-Lubricants
$95K - $102K/yr
Our products reach across automotive, trucking, agriculture, aviation, power generation, mining ... KATALYST associates experience a brief but dynamic immersion to the Phillips 66 energy value chain ...
2027 University New Hire-Lubricants
Houston, TX · On-site
$95K - $102K/yr
Our products reach across automotive, trucking, agriculture, aviation, power generation, mining ... KATALYST associates experience a brief but dynamic immersion to the Phillips 66 energy value chain ...
2027 University New Hire-Lubricants
Houston, TX · On-site
$95K - $102K/yr
Our products reach across automotive, trucking, agriculture, aviation, power generation, mining ... KATALYST associates experience a brief but dynamic immersion to the Phillips 66 energy value chain ...
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.
What makes Katalyst an attractive place to work?
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.
What are the most popular job types at Katalyst?
What are the most popular jobs at Katalyst?
What are the most popular categories at Katalyst?
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.