CSV Engineer
South Bend, IN · On-site
* Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. * The primary focus of the position will be Computer System ...
31 Katalyst Jobs Hiring in Indiana
CSV Engineer
South Bend, IN · On-site
* Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. * The primary focus of the position will be Computer System ...
Job Summary: We are seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated ...
Job Summary: We are seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated ...
Process Engineer
Bloomington, IN · On-site
The Process Engineer II supports manufacturing operations by optimizing production processes, implementing process improvements, and ensuring compliance with quality and regulatory standards. This ...
Process Engineer
Bloomington, IN · On-site
The Process Engineer II supports manufacturing operations by optimizing production processes, implementing process improvements, and ensuring compliance with quality and regulatory standards. This ...
Objectives: * Design- Support global facilities during all engineering phases. * Ensuring project meets requirements. * Delivery- Support automation for new manufacturing sites. * Project leadership.
Objectives: * Design- Support global facilities during all engineering phases. * Ensuring project meets requirements. * Delivery- Support automation for new manufacturing sites. * Project leadership.
Quality Engineer
Lafayette, IN · On-site
$69K - $89K/yr
Summary : The Quality Engineer plays a key role in proactively planning, deploying, and sustaining quality into products and processes using Caterpillar's Advanced Product Quality Planning (APQP) and ...
Quality Engineer
Lafayette, IN · On-site
$69K - $89K/yr
Summary : The Quality Engineer plays a key role in proactively planning, deploying, and sustaining quality into products and processes using Caterpillar's Advanced Product Quality Planning (APQP) and ...
Responsibilities: * Lead migration of legacy documents into Kneat digital platform, ensuring compliance and consistency. * Qualify redundant lab equipment (e.g., pH meters, thermal mixers ...
Responsibilities: * Lead migration of legacy documents into Kneat digital platform, ensuring compliance and consistency. * Qualify redundant lab equipment (e.g., pH meters, thermal mixers ...
MechanicalEngineer
Zionsville, IN · On-site
Roles & Responsibilities: * Act as technical lead for mechanical design within electromechanical medical device programs. * Own the mechanical architecture and interfaces for electromechanical ...
MechanicalEngineer
Zionsville, IN · On-site
Roles & Responsibilities: * Act as technical lead for mechanical design within electromechanical medical device programs. * Own the mechanical architecture and interfaces for electromechanical ...
Sr. Manufacturing Engineer
Warsaw, IN · On-site
$76K - $105K/yr
Summary: We are looking for an experienced Sr. Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated ...
Sr. Manufacturing Engineer
Warsaw, IN · On-site
$76K - $105K/yr
Summary: We are looking for an experienced Sr. Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated ...
* Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS). * The position is ...
* Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS). * The position is ...
CSV Engineer
Indianapolis, IN · On-site
Roles & Responsibilities: * Author equipment qualification and validation packages * Plan coordination with equipment manufacturer or supplier for preventative maintenance * Technical review and ...
CSV Engineer
Indianapolis, IN · On-site
Roles & Responsibilities: * Author equipment qualification and validation packages * Plan coordination with equipment manufacturer or supplier for preventative maintenance * Technical review and ...
MechanicalEngineer
Zionsville, IN · On-site
Roles & Responsibilities: * Act as technical lead for mechanical design within electromechanical medical device programs. * Own the mechanical architecture and interfaces for electromechanical ...
MechanicalEngineer
Zionsville, IN · On-site
Roles & Responsibilities: * Act as technical lead for mechanical design within electromechanical medical device programs. * Own the mechanical architecture and interfaces for electromechanical ...
Responsibilities: * The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. * This role ensures ...
Responsibilities: * The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. * This role ensures ...
Quality Engineer - Manufacturing
$71K - $92K/yr
Responsibilities: * Identify and document defects on the shop floor and trace similar issues in previously built units. Collect, analyze, and communicate non-conformance data effectively. * Perform ...
Quality Engineer - Manufacturing
$71K - $92K/yr
Responsibilities: * Identify and document defects on the shop floor and trace similar issues in previously built units. Collect, analyze, and communicate non-conformance data effectively. * Perform ...
CSV Engineer
Indianapolis, IN · On-site
* Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. * The primary focus of the position will be Computer System ...
CSV Engineer
Indianapolis, IN · On-site
* Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. * The primary focus of the position will be Computer System ...
Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant ...
Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant ...
Validation Engineer
Lafayette, IN · On-site
Responsibilities: * Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The consultants will support validation execution and gap assessments tied ...
Validation Engineer
Lafayette, IN · On-site
Responsibilities: * Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The consultants will support validation execution and gap assessments tied ...
Quality Systems Specialist
Notre Dame, IN · On-site
Responsibilities: * Quality Systems Specialist\Master Data Analyst with strong SAP experience to support enterprise master data governance across manufacturing, supply chain, engineering, and quality ...
Quality Systems Specialist
Notre Dame, IN · On-site
Responsibilities: * Quality Systems Specialist\Master Data Analyst with strong SAP experience to support enterprise master data governance across manufacturing, supply chain, engineering, and quality ...
Roles & Responsibilities: * Bachelor's degree in Engineering, Science, or related field. * Experience with equipment qualification, validation, or regulatory compliance. * Familiarity with Kneat ...
Roles & Responsibilities: * Bachelor's degree in Engineering, Science, or related field. * Experience with equipment qualification, validation, or regulatory compliance. * Familiarity with Kneat ...
Production Supervisor
Indianapolis, IN · On-site
Summary: The Production Supervisor oversees daily manufacturing activities to ensure production targets, quality standards, and safety requirements are consistently achieved. This role provides ...
Production Supervisor
Indianapolis, IN · On-site
Summary: The Production Supervisor oversees daily manufacturing activities to ensure production targets, quality standards, and safety requirements are consistently achieved. This role provides ...
Quality Engineer
Lafayette, IN · On-site
$69K - $89K/yr
Job Summary: We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device ...
Quality Engineer
Lafayette, IN · On-site
$69K - $89K/yr
Job Summary: We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device ...
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
Job Description:
- Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
- The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.
- Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
- Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.
Qualifications:
- Approximately 5-10 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
- Strong Computer System Validation experience.
- Experience supporting validation of GMP computerized systems.
- Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
- Understanding of data integrity and GMP expectations for computerized systems.
- Equipment validation / CQV experience in addition to CSV.
- Ability to execute established validation protocols and clearly document results.
- Experience investigating and documenting validation discrepancies or execution issues.
- Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
- ValGensis is a plus.