The MES Functional Consultant will support Manufacturing Execution System (MES) initiatives within pharmaceutical/biotech manufacturing environments. * The role involves participating in fit-gap ...

60 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 ...
Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ensuring ...
Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ensuring ...
Responsibilities: * We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. * You will work collaboratively with other functional ...
Responsibilities: * We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. * You will work collaboratively with other functional ...
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 ...
CSV Consultant
Alexandria, IN · On-site
The Program CSV Consultant will provide strategic guidance and oversight during the planning and setup of CSV deliverables for the client's Foundry Program. Responsibilities: * Interface with client ...
CSV Consultant
Alexandria, IN · On-site
The Program CSV Consultant will provide strategic guidance and oversight during the planning and setup of CSV deliverables for the client's Foundry Program. Responsibilities: * Interface with client ...
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 ...
We are seeking an experienced Track Wise QMS Consultant to support our pharmaceutical client in New Jersey. The ideal candidate will have strong expertise in Track Wise configuration, implementation ...
We are seeking an experienced Track Wise QMS Consultant to support our pharmaceutical client in New Jersey. The ideal candidate will have strong expertise in Track Wise configuration, implementation ...
Regulatory Operations Consultant
Boston, MA · On-site
* Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva ...
Regulatory Operations Consultant
Boston, MA · On-site
* Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva ...
We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Clinical, and Regulatory Affairs systems. This role will work closely with Quality ...
We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Clinical, and Regulatory Affairs systems. This role will work closely with 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)
CSV Consultant
Framingham, MA · On-site
Roles & Responsibilities : * Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management ...
CSV Consultant
Framingham, MA · On-site
Roles & Responsibilities : * Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management ...
CSV Consultant
Raritan, NJ · On-site
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 · On-site
Experience: * Experience in Validation and Testing (UAT, Regression Testing). * Experience in leading application profile, operational requirements, and business process. * 7 years of CSV relevant ...
Sr.MES Consultant
South Plainfield, NJ · On-site
Roles & Responsibilities: * Must have basic knowledge or understanding of Pharmaceutical/Medical Device compliances like 21 CFR Part 11 Compliance, GAMP, GDP etc . * Previous work experience in MES ...
Sr.MES Consultant
South Plainfield, NJ · On-site
Roles & Responsibilities: * Must have basic knowledge or understanding of Pharmaceutical/Medical Device compliances like 21 CFR Part 11 Compliance, GAMP, GDP etc . * Previous work experience in MES ...
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 ...
Responsibilities: * Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls. * Author validation plans, verification reports, and ...
Responsibilities: * Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls. * Author validation plans, verification reports, and ...
Labware LIMS Consultant
Los Angeles, CA · On-site
Summary : We are seeking a Techno-Functional Specialist with strong expertise in Labware LIMS Development with GxP-compliant process awareness and hands-on experience in ServiceNow. The ideal ...
Labware LIMS Consultant
Los Angeles, CA · On-site
Summary : We are seeking a Techno-Functional Specialist with strong expertise in Labware LIMS Development with GxP-compliant process awareness and hands-on experience in ServiceNow. The ideal ...
CSV Lead Consultant
Avenel, NJ · On-site
Roles & Responsibilities: * 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems.
CSV Lead Consultant
Avenel, NJ · On-site
Roles & Responsibilities: * 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems.
Senior CSV Consultant
Portsmouth, NH · On-site
Roles & Responsibilities: * Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC. * Author, review, approve, and execute Computer System ...
Senior CSV Consultant
Portsmouth, NH · On-site
Roles & Responsibilities: * Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC. * Author, review, approve, and execute Computer System ...
Roles & Responsibilities : * Provide day-to-day technical support for serialization systems (vision systems, printers, scanners, PLCs) in 247 support environment. * Troubleshoot and resolve ...
Roles & Responsibilities : * Provide day-to-day technical support for serialization systems (vision systems, printers, scanners, PLCs) in 247 support environment. * Troubleshoot and resolve ...
Katalyst Jobs Information
What are the key skills and qualifications needed to thrive as a Consultant, and why are they important?
What are some typical challenges faced by consultants when working with new clients, and how can they be navigated?
What is consulting?
What exactly is a consulting job?
What jobs make $3,000 a month without a degree?
What is the difference between Consulting vs Data Analyst?
| Aspect | Consulting | Data Analyst |
|---|---|---|
| Required Credentials | Bachelor's degree, often advanced degrees in business or related fields | Bachelor's or master's in statistics, mathematics, or related fields |
| Work Environment | Client sites, consulting firms, or remote | Office settings, data centers, or remote |
| Employer & Industry Usage | Consulting firms, corporations, government agencies | Corporations, research firms, government agencies |
| Common Search & Comparison | Consulting vs Data Analyst |
While both roles involve problem-solving and analysis, Consulting focuses on advising clients across various industries on strategic issues, whereas Data Analysts primarily interpret data to inform business decisions within organizations. Consulting often requires strong communication skills and client management, while Data Analysts emphasize technical data skills and statistical analysis.
What is it like to work at Katalyst?
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.
Job description
- 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.