Summary: Our client, a leading biologics manufacturing company, is seeking an experienced Cleaning Validation Specialist to support cleaning validation activities for equipment upgrade projects ...
33 Katalyst Jobs Hiring in Minnesota
Summary: Our client, a leading biologics manufacturing company, is seeking an experienced Cleaning Validation Specialist to support cleaning validation activities for equipment upgrade projects ...
Senior Quality Engineer
Champlin, MN · On-site
$90K - $122K/yr
Summary: We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. Roles & Responsibilities: * 10+ years of Quality Engineering ...
Senior Quality Engineer
Champlin, MN · On-site
$90K - $122K/yr
Summary: We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. Roles & Responsibilities: * 10+ years of Quality Engineering ...
Supplier Quality Engineer
Plymouth, MN · On-site
Summary : We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality ...
Supplier Quality Engineer
Plymouth, MN · On-site
Summary : We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality ...
Supplier Quality Engineer
Saint Paul, MN · On-site
The Supplier Engineer II will focus on value improvement projects, new product introduction, & sustaining projects for the Connectors and Cable Assemblies category team. This role partners with cross ...
Supplier Quality Engineer
Saint Paul, MN · On-site
The Supplier Engineer II will focus on value improvement projects, new product introduction, & sustaining projects for the Connectors and Cable Assemblies category team. This role partners with cross ...
Verification Test Engineer
Chaska, MN · On-site
$145K/yr
The Verification Test Engineer (Contract) will support verification activities for complex instrumentation systems. This role is responsible for instrument maintenance, execution of verification ...
Verification Test Engineer
Chaska, MN · On-site
$145K/yr
The Verification Test Engineer (Contract) will support verification activities for complex instrumentation systems. This role is responsible for instrument maintenance, execution of verification ...
Equipment Engineer
Minneapolis, MN · On-site
Responsibilities: * Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment.
Equipment Engineer
Minneapolis, MN · On-site
Responsibilities: * Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment.
* Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division.
* Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division.
Validation Specialist
Minneapolis, MN · On-site
Job Summary: * This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area.
Validation Specialist
Minneapolis, MN · On-site
Job Summary: * This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area.
Project Manager - CIA, MedTech
$102K - $121K/yr
Job Summary: We are looking for a results-driven Project Manager to support CIA initiatives in a fast-paced medical device environment. This role requires strong leadership, stakeholder management ...
Project Manager - CIA, MedTech
$102K - $121K/yr
Job Summary: We are looking for a results-driven Project Manager to support CIA initiatives in a fast-paced medical device environment. This role requires strong leadership, stakeholder management ...
Manufacturing Engineer II
Saint Paul, MN · On-site
$73K - $95K/yr
Job Summary: * The role focuses on integration of the legacy CSI quality management system into the Client quality management system, with an emphasis on documentation review, execution of protocols ...
Manufacturing Engineer II
Saint Paul, MN · On-site
$73K - $95K/yr
Job Summary: * The role focuses on integration of the legacy CSI quality management system into the Client quality management system, with an emphasis on documentation review, execution of protocols ...
Sr. SAS Programmer
Minneapolis, MN · On-site
Responsibilities: * To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and ...
Sr. SAS Programmer
Minneapolis, MN · On-site
Responsibilities: * To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and ...
Quality Engineer
Fairmont, MN · On-site
$71K - $92K/yr
Roles & Responsibilities: * Supporting and interacting with suppliers and customers through complaint investigations, resolution, and trending * Ensuring the commercialized product design intent and ...
Quality Engineer
Fairmont, MN · On-site
$71K - $92K/yr
Roles & Responsibilities: * Supporting and interacting with suppliers and customers through complaint investigations, resolution, and trending * Ensuring the commercialized product design intent and ...
Supplier Quality Engineer
Plymouth, MN · On-site
Job Summary: * We are looking for an experienced Supplier Quality Engineer with a strong background in the Medical Device industry. Responsibilities: * Perform Supplier Quality and Receiving ...
Supplier Quality Engineer
Plymouth, MN · On-site
Job Summary: * We are looking for an experienced Supplier Quality Engineer with a strong background in the Medical Device industry. Responsibilities: * Perform Supplier Quality and Receiving ...
Summary * The Systems Engineer will support the overall technical direction of Acute Therapies products. This role involves contributing across the full product development lifecycle--from ...
Summary * The Systems Engineer will support the overall technical direction of Acute Therapies products. This role involves contributing across the full product development lifecycle--from ...
* This person must be able to travel 5-10% globally (possibly Sweden, China, Finland, also local.) Approximately 5-10 trips per year. * As a Principal Supplier Engineer, you'll be the bridge between ...
* This person must be able to travel 5-10% globally (possibly Sweden, China, Finland, also local.) Approximately 5-10 trips per year. * As a Principal Supplier Engineer, you'll be the bridge between ...
Quality Assurance
Saint Paul, MN · On-site
We are looking for a Quality Operations - QA Specialist to support daily quality assurance activities at our client site in Morris Plains, NJ. The candidate will ensure that manufacturing, packaging ...
Quality Assurance
Saint Paul, MN · On-site
We are looking for a Quality Operations - QA Specialist to support daily quality assurance activities at our client site in Morris Plains, NJ. The candidate will ensure that manufacturing, packaging ...
Validation Engineer
Minneapolis, MN · On-site
Job Summary: * We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within ...
Validation Engineer
Minneapolis, MN · On-site
Job Summary: * We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within ...
Design Quality engineer
Plymouth, MN · On-site
Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ...
Design Quality engineer
Plymouth, MN · On-site
Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ...
Labeling Engineer
Minneapolis, MN · On-site
* We are seeking a highly skilled Medical Device Labeling Engineer with strong expertise in regulatory compliance, labeling development, and cross-functional coordination. This role also involves ...
Labeling Engineer
Minneapolis, MN · On-site
* We are seeking a highly skilled Medical Device Labeling Engineer with strong expertise in regulatory compliance, labeling development, and cross-functional coordination. This role also involves ...
R&D Engineer
Minneapolis, MN · On-site
Job Summary: * The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams ...
R&D Engineer
Minneapolis, MN · On-site
Job Summary: * The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams ...
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.
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Job description
Summary:
Our client, a leading biologics manufacturing company, is seeking an experienced Cleaning Validation Specialist to support cleaning validation activities for equipment upgrade projects within a cGMP manufacturing environment. This role will focus on developing and executing cleaning validation protocols for equipment such as centrifuges, CIP skids, transfer panels, and heat exchangers using Kneat Gx. The ideal candidate will have hands-on pharmaceutical or biotechnology cleaning validation experience, strong technical writing skills, and the ability to work collaboratively with cross-functional teams.
Roles & Responsibilities:
Our client, a leading biologics manufacturing company, is seeking an experienced Cleaning Validation Specialist to support cleaning validation activities for equipment upgrade projects within a cGMP manufacturing environment. This role will focus on developing and executing cleaning validation protocols for equipment such as centrifuges, CIP skids, transfer panels, and heat exchangers using Kneat Gx. The ideal candidate will have hands-on pharmaceutical or biotechnology cleaning validation experience, strong technical writing skills, and the ability to work collaboratively with cross-functional teams.
Roles & Responsibilities:
- Develop and author Cleaning Validation Protocols using Kneat Gx or similar electronic validation systems.
- Execute cleaning validation activities, including sampling, data collection, protocol execution, and documentation.
- Support validation of equipment upgrades, including centrifuges, CIP skids, transfer panels, and heat exchangers.
- Investigate validation issues, support troubleshooting activities, and perform protocol revisions or re-execution as required.
- Prepare and support cleaning validation reports, ensuring timely documentation and project closeout.
- Collaborate with cross-functional teams including SMEs, Quality Assurance (QA), Engineering, Manufacturing, and contractors.
- Ensure all validation activities comply with cGMP, company procedures, and regulatory requirements.
- Maintain accurate validation documentation and support audit readiness throughout project execution.
- Bachelor's degree in Engineering, Life Sciences, or a related discipline (or equivalent industry experience).
- Hands-on experience in Cleaning Validation within a cGMP pharmaceutical or biotechnology manufacturing environment.
- Experience authoring and executing cleaning validation protocols using Kneat Gx or similar electronic validation systems.
- Strong technical writing and documentation skills.
- Experience with cleaning validation of manufacturing equipment such as:
o CIP (Clean-In-Place) Systems
o SIP (Steam-In-Place) Systems
o Centrifuges
o Bioreactors
o Heat Exchangers
o Transfer Panels
o SIP (Steam-In-Place) Systems
o Centrifuges
o Bioreactors
o Heat Exchangers
o Transfer Panels
- Strong understanding of cGMP documentation and validation lifecycle.
- Ability to work full-time onsite in the Twin Cities Metro during project execution.
- Experience supporting biologics or large molecule manufacturing facilities.
- Experience with equipment replacement, facility upgrades, or technology transfer projects.
- Familiarity with cross-functional project execution in regulated pharmaceutical manufacturing environments.