The MES Functional Consultant will support Manufacturing Execution System (MES) initiatives within pharmaceutical/biotech manufacturing environments. * The role involves participating in fit-gap ...
42 Katalyst Consulting Jobs Hiring Near You
The MES Functional Consultant will support Manufacturing Execution System (MES) initiatives within pharmaceutical/biotech manufacturing environments. * The role involves participating in fit-gap ...
QMS Consultant
Blue Ash, OH · On-site
We are seeking a QMS Consultant to support and maintain Quality Management System (QMS) processes for medical device projects in compliance with regulatory requirements. The ideal candidate will ...
QMS Consultant
Blue Ash, OH · On-site
We are seeking a QMS Consultant to support and maintain Quality Management System (QMS) processes for medical device projects in compliance with regulatory requirements. The ideal candidate will ...
CSV Consultant
Raritan, NJ · Remote
CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches. * The role ...
CSV Consultant
Raritan, NJ · Remote
CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches. * The role ...
* QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality ...
* QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality ...
QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality ...
QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality ...
Experience consulting or working in a complex, global matrix organization * (preferred) * Knowledge of Lean operational techniques (preferred)
Experience consulting or working in a complex, global matrix organization * (preferred) * Knowledge of Lean operational techniques (preferred)
Experience: * Experience in Validation and Testing (UAT, Regression Testing). * Experience in leading application profile, operational requirements, and business process. * 7 years of CSV relevant ...
Experience: * Experience in Validation and Testing (UAT, Regression Testing). * Experience in leading application profile, operational requirements, and business process. * 7 years of CSV relevant ...
CSV Consultant
Raritan, NJ · Remote
Roles & Responsibilities: * Ex-Pharmaceutical preferred. * Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years' experience with System Development Lifecyle. * 3+ ...
CSV Consultant
Raritan, NJ · Remote
Roles & Responsibilities: * Ex-Pharmaceutical preferred. * Experience in the Pharmaceutical, biotechnology, or medical device industry. * 2+ years' experience with System Development Lifecyle. * 3+ ...
Responsibilities: * Our client is a global immunology company committed to improving the lives of individuals who have severe autoimmune diseases with their Client antibody-based medicines. * They ...
Responsibilities: * Our client is a global immunology company committed to improving the lives of individuals who have severe autoimmune diseases with their Client antibody-based medicines. * They ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment ...
As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such ...
As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create related documents such ...
CSV Lead
$101K - $133K/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
$101K - $133K/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 ...
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 Summary:
- The MES Functional Consultant will support Manufacturing Execution System (MES) initiatives within pharmaceutical/biotech manufacturing environments.
- The role involves participating in fit-gap analysis, process modeling, Electronic Batch Record (EBR) configuration, validation activities, troubleshooting PharmaSuite MES issues, and supporting go-live/hypercare activities.
- The consultant will collaborate with cross-functional teams, business stakeholders, process SMEs, and technical teams to deliver compliant and efficient MES solutions aligned with manufacturing and IT standards.
- Participate in fit-gap analysis sessions, process modeling, and process standardization activities with business stakeholders and process SMEs.
- Collaborate with lead business analysts and requirement analysts to develop business and functional requirements.
- Provide effort estimations, user story point estimations, and status updates for assigned tasks and deliverables.
- Configure and maintain Electronic Batch Records (EBRs) in Development, Stage, and Production environments.
- Author, review, and execute validation documentation supporting MES/EBR implementations including IQ/OQ and related validation activities.
- Troubleshoot and resolve issues related to PharmaSuite MES and associated manufacturing systems.
- Work closely with site teams to address site-specific use cases, enhancement requests (ERs), and operational requirements.
- Coordinate across functional and technical teams to gather requirements and support EBR development activities.
- Provide HyperCare and Go-Live support during MES deployments and production rollouts.
- Ensure compliance with IT lifecycle management processes, IT business process models, and ISA/S95 standards.
- Support continuous improvement initiatives related to MES processes and manufacturing operations.
- Communicate effectively with global teams, business users, and technical stakeholders.
- Bachelor's degree in Engineering, Information Technology, Computer Science, Biotechnology, Pharmaceutical Sciences, or related field.
- Experience working with Manufacturing Execution Systems (MES), preferably PharmaSuite MES.
- Strong understanding of pharmaceutical or biotech manufacturing processes and manufacturing systems.
- Experience with Electronic Batch Record (EBR) configuration and MES validation activities.
- Knowledge of IT lifecycle management, IT business process models, and ISA/S95 standards.
- Hands-on experience in troubleshooting and resolving MES-related production/support issues.
- Experience developing and executing IQ/OQ and validation documentation.
- Strong analytical, problem-solving, and process improvement skills.
- Excellent verbal and written communication skills.
- Ability to work in cross-functional and fast-paced project environments.