The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
42 Katalyst Consulting Jobs Hiring Near You
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
CSV Lead
$99K - $131K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
CSV Lead
$99K - $131K/yr
The selected consultant will report to the Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on ...
We are seeking a Lead CSV / Validation Consultant (Director-Level) for a biotech client with an upcoming FDA inspection. This is a critical position focused on program maturity, SaaS validation, and ...
We are seeking a Lead CSV / Validation Consultant (Director-Level) for a biotech client with an upcoming FDA inspection. This is a critical position focused on program maturity, SaaS validation, and ...
Our client is looking for an experienced and well-rounded CSV (Computer System Validation) Consultant to support multiple ongoing projects within a pharmaceutical environment. The ideal candidate ...
Our client is looking for an experienced and well-rounded CSV (Computer System Validation) Consultant to support multiple ongoing projects within a pharmaceutical environment. The ideal candidate ...
CSV Lead (Managed Services)
$107K - $141K/yr
Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team. * Support Engagement Lead with resource interviews, allocation, utilization, schedule ...
CSV Lead (Managed Services)
$107K - $141K/yr
Manage and support CSV Consultants on execution responsibilities & be direct interface to customer FT team. * Support Engagement Lead with resource interviews, allocation, utilization, schedule ...
Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. * Strong ...
Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. * Strong ...
Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible ...
Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
Manage high complex studies and support specific activities of studies managed by other data managers or consultants * Provide technical tutoring and supervise data managers and/or contractors ...
Manage high complex studies and support specific activities of studies managed by other data managers or consultants * Provide technical tutoring and supervise data managers and/or contractors ...
Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management ...
Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. * The ideal candidate will have ...
... consultants as needed. * Document regulatory strategies for product submissions. * Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
... consultants as needed. * Document regulatory strategies for product submissions. * Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
Uses judgment and consultation to analyze, troubleshoot and repair complex equipment and machinery. Must project positive attitude with good team skills. Effectively works in a team setting ...
This consultant will assess existing quality processes, identify compliance gaps related to raw materials and components, develop and execute remediation plans, and partner with cross-functional ...
This consultant will assess existing quality processes, identify compliance gaps related to raw materials and components, develop and execute remediation plans, and partner with cross-functional ...
Global Supply Chain Management with Vertex. (100% Remote role) Below is the job description for your
South Plainfield, NJ · Remote
The Project Manager will also be responsible for collaboration with project managers from external consulting/implementation services teams to ensure successful joint outcomes and accurate management ...
Global Supply Chain Management with Vertex. (100% Remote role) Below is the job description for your
South Plainfield, NJ · Remote
The Project Manager will also be responsible for collaboration with project managers from external consulting/implementation services teams to ensure successful joint outcomes and accurate management ...
Job Summary: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments.
Job Summary: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments.
... consultation with the study principal investigator * Serve as subject matter expert on appropriate use cases for, and nuances of, the variety of different Flatiron data modalities, including EHR ...
... consultation with the study principal investigator * Serve as subject matter expert on appropriate use cases for, and nuances of, the variety of different Flatiron data modalities, including EHR ...
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 jobs at Katalyst?
What are the most popular categories at Katalyst?
Job description
- We are seeking an experienced CSV Lead to support the validation of computer systems for a newly constructed Sterile Drug Product Clinical Manufacturing Facility. 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 Automation Lead and work alongside a team of Automation Engineers already involved in the facility and equipment system design. The role will focus on leading and supporting the development of the CSV approach in alignment with company policies and independently from the existing commercial organization.
- The consultant will lead the development and execution of CSV documentation and validation activities and is expected to support validation execution activities through 2027.
- This position requires a highly experienced professional who can work independently in a fast-paced project environment and accommodate flexible work schedules as needed to support project delivery timelines.
- Lead development and execution of CSV strategy and documentation.
- Support validation activities for computer systems associated with sterile drug product manufacturing.
- Develop and execute CSV lifecycle documents including protocols and reports.
- Collaborate with Automation Engineers and cross-functional project teams.
- Support investigation and resolution of technical protocol deviations.
- Participate in validation execution activities throughout the project lifecycle.
- Support testing activities related to field I/O, instrumentation, and control systems.
- Ensure compliance with cGMP and regulatory requirements
- 10–15 years of Computer System Validation (CSV) experience.
- Strong pharmaceutical or biotech manufacturing experience.
- Experience supporting sterile manufacturing facilities preferred.
- Ability to work independently with minimal supervision.
- Strong communication and troubleshooting skills.
- Experience supporting large capital projects preferred.
- AVEVA System Platform.
- Allen Bradley PLC.
- Siemens PLC.
- AVEVA PI Historian.
- Alarm Management Systems.
- Particle and Equipment Monitoring Systems.
- Understanding of Operational Technology (OT) concepts.
- Hands-on experience supporting testing of field I/O, instrumentation, and control systems.
- Experience with SCADA, HMI, and Client platforms.
- Experience with communications and network infrastructure.
- Experience supporting Robotic Isolator and Filling Line systems.
- Experience supporting Lyophilization processes.
- Experience with Formulation and Wash Isolators.
- Experience supporting Autoclave and Equipment Wash systems.
- Experience with Door Interlocking PLC systems.
- Kneat experience preferred.
- Project schedule may require flexible work hours.
- Candidate must be comfortable working in a dynamic project environment.
- Strong collaboration skills required within R&D and engineering project teams.