Lead and execute commissioning and qualification activities for new secondary and tertiary ... Collaborate with equipment vendors, engineering, construction, and operations teams to ensure ...

72 Katalyst Lead Engineer Jobs Hiring Near You
Lead and execute commissioning and qualification activities for new secondary and tertiary ... Collaborate with equipment vendors, engineering, construction, and operations teams to ensure ...
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and ... Lead commissioning, qualification, and validation activities for automated and semi-automated ...
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and ... Lead commissioning, qualification, and validation activities for automated and semi-automated ...
Software Engineer L1
Raymond, OH · On-site
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 ...
Software Engineer L1
Raymond, OH · On-site
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 ...
Lead/Support a Veeva LIMS implementation and the validation activities throughout the system ... Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical ...
Lead/Support a Veeva LIMS implementation and the validation activities throughout the system ... Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related 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 ...
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 ...
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 ...
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 ...
Design Engineer L2
Raymond, OH · Hybrid
Qualification: * BS/MS in Mechanical Engineering.
Design Engineer L2
Raymond, OH · Hybrid
Qualification: * BS/MS in Mechanical Engineering.
We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and manufacturing ...
We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and manufacturing ...
Lead initiatives to enhance Quality Management Systems (QMS) across manufacturing operations ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...
Lead initiatives to enhance Quality Management Systems (QMS) across manufacturing operations ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...
Mechanical Tool Designer
Delaware, OH · On-site
Perform engineering calculations with respect to strength of materials, speeds, horsepower, temperature, pressure, force, etc. as related to machine and tool designs. * Analyzes engineering drawings ...
Mechanical Tool Designer
Delaware, OH · On-site
Perform engineering calculations with respect to strength of materials, speeds, horsepower, temperature, pressure, force, etc. as related to machine and tool designs. * Analyzes engineering drawings ...
Procurement Specialist
Columbus, OH · On-site
Summary: The Procurement Specialist is responsible for supporting sourcing activities, managing supplier relationships, and ensuring timely procurement of materials and services. This role works ...
Procurement Specialist
Columbus, OH · On-site
Summary: The Procurement Specialist is responsible for supporting sourcing activities, managing supplier relationships, and ensuring timely procurement of materials and services. This role works ...
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 ...
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 ...
... lead programmer for NDAs/BLAs. • Experience overseeing the work of internal contractors and external vendors (CROs). Company : Katalyst CRO | Advancing Healthcare & Life Sciences with Expert ...
... lead programmer for NDAs/BLAs. • Experience overseeing the work of internal contractors and external vendors (CROs). Company : Katalyst CRO | Advancing Healthcare & Life Sciences with Expert ...
Senior Space Systems Engineer
Broomfield, CO · On-site
$130K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead detailed technical efforts and spearhead trade studies of space system architectures
Senior Space Systems Engineer
Broomfield, CO · On-site
$130K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead detailed technical efforts and spearhead trade studies of space system architectures
Mechanical Engineering Manager
Broomfield, CO · On-site
$139K - $225K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead and grow the Mechanical Engineering organization spanning robotics, bus design, arrays and ...
Mechanical Engineering Manager
Broomfield, CO · On-site
$139K - $225K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead and grow the Mechanical Engineering organization spanning robotics, bus design, arrays and ...
Senior Systems Engineer
Broomfield, CO · On-site
$120K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead system architecture, requirements development, and technical execution for advanced robotic ...
Senior Systems Engineer
Broomfield, CO · On-site
$120K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead system architecture, requirements development, and technical execution for advanced robotic ...
Senior Space Systems Engineer
Broomfield, CO · On-site
$130K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead detailed technical efforts and spearhead trade studies of space system architectures
Senior Space Systems Engineer
Broomfield, CO · On-site
$130K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead detailed technical efforts and spearhead trade studies of space system architectures
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and ...
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and ...
Principal Systems Engineer
Broomfield, CO · On-site
$140K - $205K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead system architecture, requirements development, and technical execution for advanced robotic ...
Principal Systems Engineer
Broomfield, CO · On-site
$140K - $205K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead system architecture, requirements development, and technical execution for advanced robotic ...
Senior Systems Engineer
Broomfield, CO · On-site
$120K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead system architecture, requirements development, and technical execution for advanced robotic ...
Senior Systems Engineer
Broomfield, CO · On-site
$120K - $180K/yr
Katalyst Description: Katalyst is an American technology company focused on dynamic space ... Lead system architecture, requirements development, and technical execution for advanced robotic ...
Katalyst Jobs Information
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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
- We are looking for an experienced Commissioning & Qualification (C&Q) Engineer to join our team in support of a major capital expansion project involving the installation of four new packaging lines.
- This is a hands-on C&Q role embedded within a pharmaceutical secondary and tertiary packaging operation for final drug 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 regulated pharmaceutical environment.
- You will be responsible for leading and executing commissioning and qualification activities across new packaging equipment installations, ensuring all systems are built, installed, and functionally verified to specification and ready for handover to GMP manufacturing operations.
- Lead and execute commissioning and qualification activities for new secondary and tertiary packaging equipment installations across four new packaging lines in Building 2
- Develop, author, review, and execute C&Q documentation including commissioning plans, commissioning protocols, test scripts, punch lists, and turnover packages
- Perform hands-on equipment walkdowns, system verifications, and commissioning checks directly on the manufacturing floor
- Manage punch list identification, tracking, and resolution through to system acceptance and turnover
- Collaborate with equipment vendors, engineering, construction, and operations teams to ensure systems are installed, functional, and commissioned to design specification
- Support and execute SAT (Site Acceptance Testing) activities for incoming packaging equipment
- Ensure all C&Q activities are performed in compliance with FDA, GMP, and applicable site and regulatory standards
- Apply manufacturing process knowledge to ensure commissioning scope and acceptance criteria reflect real-world operational requirements
- Partner with Quality, Manufacturing, and Engineering to support a clean, compliant turnover of commissioned systems into GMP operations
- Maintain accurate and complete C&Q records in compliance with site documentation standards and data integrity requirements
- Experienced Commissioning & Qualification (C&Q) professional with deep expertise in equipment commissioning, system turnover, and manufacturing process knowledge within a regulated pharmaceutical environment
- Experience supporting pharmaceutical secondary and tertiary packaging operations for final drug product
- Hands-on experience in equipment commissioning, system turnover, and manufacturing floor execution
- Knowledge of FDA, GMP, and applicable site and regulatory standards