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 ...

63 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 ...
C&Q Engineer
New Albany, OH · On-site
... 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 ...
C&Q Engineer
New Albany, OH · On-site
... 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 ...
CSV Engineer
Columbus, OH · On-site
... manufacturing operations by leading validation activities for key systems, including Veeva QMS ... ensuring product quality, patient safety, and regulatory inspection readiness. Roles ...
CSV Engineer
Columbus, OH · On-site
... manufacturing operations by leading validation activities for key systems, including Veeva QMS ... ensuring product quality, patient safety, and regulatory inspection readiness. Roles ...
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: We build robotic spacecraft that enable dynamic space operations, creating a ... and production. * Build and manage relationships with suppliers, manufacturers, and strategic ...
Supply Chain Manager
Broomfield, CO · On-site
$105K - $135K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a ... and production. * Build and manage relationships with suppliers, manufacturers, and strategic ...
Quality Engineer
Broomfield, CO · On-site
$110K - $145K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a ... Lead process improvement initiatives to reduce defects, improve yield, and increase production ...
Quality Engineer
Broomfield, CO · On-site
$110K - $145K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a ... Lead process improvement initiatives to reduce defects, improve yield, and increase production ...
Quality Engineer
Broomfield, CO · On-site
$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
Broomfield, CO · On-site
$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 ...
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 ...
Process Engineer
Antioch, IL · On-site
Sterile drug product manufacturing. * GMP pharma process validation. * Experience working with CMOs. * Ability to travel (domestic and/or international). Key Stakeholders: * Manufacturing. * Quality.
Process Engineer
Antioch, IL · On-site
Sterile drug product manufacturing. * GMP pharma process validation. * Experience working with CMOs. * Ability to travel (domestic and/or international). Key Stakeholders: * Manufacturing. * Quality.
Process Engineer
Morristown, NJ · On-site
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 ...
Process Engineer
Morristown, NJ · On-site
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 ...
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 ...
Process Engineer
Antioch, IL · On-site
Sterile drug product manufacturing. * GMP pharma process validation. * Experience working with CMOs. * Ability to travel (domestic and/or international). Key Stakeholders: * Manufacturing. * Quality.
Process Engineer
Antioch, IL · On-site
Sterile drug product manufacturing. * GMP pharma process validation. * Experience working with CMOs. * Ability to travel (domestic and/or international). Key Stakeholders: * Manufacturing. * Quality.
Process Engineer
Morristown, NJ · On-site
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 ...
Process Engineer
Morristown, NJ · On-site
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 ...
CSV Lead
Harrisburg, PA · On-site
$101K - $133K/yr
This role will play a key part in supporting the transition from the existing Sterile Drug Product Clinical Manufacturing facility planned for 2028. * The selected consultant will report to the ...
CSV Lead
Harrisburg, PA · On-site
$101K - $133K/yr
This role will play a key part in supporting the transition from the existing Sterile Drug Product Clinical Manufacturing facility planned for 2028. * The selected consultant will report to the ...
CSV Lead
Philadelphia, PA · On-site
$98K - $129K/yr
This role will play a key part in supporting the transition from the existing Sterile Drug Product Clinical Manufacturing facility planned for 2028. * The selected consultant will report to the ...
CSV Lead
Philadelphia, PA · On-site
$98K - $129K/yr
This role will play a key part in supporting the transition from the existing Sterile Drug Product Clinical Manufacturing facility planned for 2028. * The selected consultant will report to the ...
CSV Lead
Lancaster, PA · On-site
$99K - $131K/yr
This role will play a key part in supporting the transition from the existing Sterile Drug Product Clinical Manufacturing facility planned for 2028. * The selected consultant will report to the ...
CSV Lead
Lancaster, PA · On-site
$99K - $131K/yr
This role will play a key part in supporting the transition from the existing Sterile Drug Product Clinical Manufacturing facility planned for 2028. * The selected consultant will report to the ...
Validation Engineer
North Haven, CT · On-site
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Clean Room experience and medical prod mfg exp (added advantage). * Communicates with stakeholders ...
Validation Engineer
North Haven, CT · On-site
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Clean Room experience and medical prod mfg exp (added advantage). * Communicates with stakeholders ...
Sr. Principal Engineer
Round Lake, IL · On-site
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... new product packaging and assist the manufacturing plants in qualification of new packaging ...
Sr. Principal Engineer
Round Lake, IL · On-site
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... new product packaging and assist the manufacturing plants in qualification of new packaging ...
Manufacturing Engineer
Carnegie, PA · On-site
$70K - $90K/yr
Support production line requirements, workstation concepts, tooling, fixtures, equipment interfaces, and process documentation. * Collaborate with Engineering, Operations, Quality, Supply Chain ...
Manufacturing Engineer
Carnegie, PA · On-site
$70K - $90K/yr
Support production line requirements, workstation concepts, tooling, fixtures, equipment interfaces, and process documentation. * Collaborate with Engineering, Operations, Quality, Supply Chain ...
Katalyst Jobs Information
What is it like to work at Katalyst?
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?

Job description
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.