Job Summary: * The MES Functional Consultant will support Manufacturing Execution System (MES) initiatives within pharmaceutical/biotech manufacturing environments. * The role involves participating ...
Katalyst
60 jobs near Princeton, NJ
Job Summary: * The MES Functional Consultant will support Manufacturing Execution System (MES) initiatives within pharmaceutical/biotech manufacturing environments. * The role involves participating ...
Responsibilities: * Ensure departmental or functional training plans in place and appropriate * Perform vendor qualifications regarding statistical programming functions and manage CRO programming ...
Responsibilities: * Ensure departmental or functional training plans in place and appropriate * Perform vendor qualifications regarding statistical programming functions and manage CRO programming ...
Responsibilities: * Process and Cleaning Validation Experience. * Equipment Qualification (IOQ/PQ). * Quality System Experience (Veeva, Track wise, Compliance Wire). * Medical Device or ...
Responsibilities: * Process and Cleaning Validation Experience. * Equipment Qualification (IOQ/PQ). * Quality System Experience (Veeva, Track wise, Compliance Wire). * Medical Device or ...
Design Quality Engineer Environment: Our client is a large medical device manufacturer that develops a number of Medical Device products. They are currently in need of an experienced Design Quality ...
Design Quality Engineer Environment: Our client is a large medical device manufacturer that develops a number of Medical Device products. They are currently in need of an experienced Design Quality ...
Roles and Responsibilities: * eCRF Design - Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations in eCRF design and works with ...
Roles and Responsibilities: * eCRF Design - Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations in eCRF design and works with ...
Summary: We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes ...
Summary: We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes ...
Summary : * Develop qualification plans for supplier transfer projects and complete associated verification testing. * Manage and execute Engineering Change Requests (ECRs) and Engineering Change ...
Summary : * Develop qualification plans for supplier transfer projects and complete associated verification testing. * Manage and execute Engineering Change Requests (ECRs) and Engineering Change ...
Roles and Responsibilities: * Lead end-to-end Computer System Validation for GxP systems. * Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports. * Ensure compliance ...
Roles and Responsibilities: * Lead end-to-end Computer System Validation for GxP systems. * Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports. * Ensure compliance ...
Summary: Results-driven Software & Systems Verification Engineer with 5+ years of experience in FDA-regulated medical devices, embedded systems, and molecular diagnostics. Expertise in Software ...
Summary: Results-driven Software & Systems Verification Engineer with 5+ years of experience in FDA-regulated medical devices, embedded systems, and molecular diagnostics. Expertise in Software ...
Roles & Responsibilities : * Develop and execute validation strategies * Lead Process Validation & PPQ activities * Perform C&Q for equipment, utilities, and facility systems * Run risk and gap ...
Roles & Responsibilities : * Develop and execute validation strategies * Lead Process Validation & PPQ activities * Perform C&Q for equipment, utilities, and facility systems * Run risk and gap ...
Summary: IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on ...
Summary: IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on ...
Summary : This Supplier Quality Engineering position will have responsibility for oversight and improvement of a selected sub-set of Opco's component and sub-assembly suppliers. Roles ...
Summary : This Supplier Quality Engineering position will have responsibility for oversight and improvement of a selected sub-set of Opco's component and sub-assembly suppliers. Roles ...
CQV Engineer
$107.10K - $141.10K/yr
Job Summary : * The Plant Utilities Commissioning & Qualification (C&Q) Lead is responsible for directing and executing all commissioning activities for plant utility systems-including chilled water ...
CQV Engineer
$107.10K - $141.10K/yr
Job Summary : * The Plant Utilities Commissioning & Qualification (C&Q) Lead is responsible for directing and executing all commissioning activities for plant utility systems-including chilled water ...
Global Supply Chain Management with Vertex. (100% Remote role) Below is the job description for your
South Plainfield, NJ · Remote
Work you will do : The Project Manager, Global Supply Chain Management is a role within the DTE Project Management & Strategic Operations team reporting directly to the Senior Director, Technology ...
Global Supply Chain Management with Vertex. (100% Remote role) Below is the job description for your
South Plainfield, NJ · Remote
Work you will do : The Project Manager, Global Supply Chain Management is a role within the DTE Project Management & Strategic Operations team reporting directly to the Senior Director, Technology ...
The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working ...
The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working ...
Roles & Responsibilities: * Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk * Create/write validation documentation (VP/URS/FS/DS/Trace Matrix ...
Roles & Responsibilities: * Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk * Create/write validation documentation (VP/URS/FS/DS/Trace Matrix ...
CSA/CSV Lead
South Plainfield, NJ · Remote
Summary: The CSA Lead provides leadership and execution oversight for computer system assurance and validation activities supporting SAP Unify Release 1.0 and 1.5. The role is responsible for ...
CSA/CSV Lead
South Plainfield, NJ · Remote
Summary: The CSA Lead provides leadership and execution oversight for computer system assurance and validation activities supporting SAP Unify Release 1.0 and 1.5. The role is responsible for ...
QUALITY ENGINEER II
$75.20K - $97.20K/yr
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality ...
QUALITY ENGINEER II
$75.20K - $97.20K/yr
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality ...
Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves ...
Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves ...
CSV for SAP systems/projects To create| assign and track the project [module] work plans for delivery and also provide technical guidance for work completion. (1.) To ensure process improvement and ...
CSV for SAP systems/projects To create| assign and track the project [module] work plans for delivery and also provide technical guidance for work completion. (1.) To ensure process improvement and ...
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.