Provide validation and documentation support for Manufacturing Execution Systems (MES) and Electronic Batch Records (eBRs) in a regulated pharmaceutical manufacturing environment.
Responsibilities
Develop, review, update, execute, and maintain computerized system validation documentation in accordance with GMP regulations and data integrity principles.
Support validation lifecycle documentation including URS, Functional Specifications, Design Specifications, Configuration Specifications, Risk Assessments, and Traceability Matrices.
Develop and execute IQ/OQ testing protocols and document validation results.
Coordinate activities with cross‑functional technical and business teams.
Prepare and review validation reports and summary reports.
Requirements
Bachelor’s degree in engineering, Computer Science, Information Technology, Life Sciences, Chemistry, or a related technical discipline
Nice to have: Syncade Enterprise MES (EMES)
Nice to have: Electronic batch record implementation
The Controlling Enablement Data Integrity Senior Expert participates on the design and the deployment of standardized processes and rules in the Core Model, focusing on data integrity for TM1 satellites.
Compensation
The salary range for this position is :Ft10 944 000,00 - Ft14 592 000
Responsibilities
Participate in implementation of the strategy roadmap in the controlling core model
Establish close relationships and coordinate with relevant teams
Pilot the execution of process improvement initiatives
Collaborate on the design and the deployment of standardized processes and rules globally
Participate in the definition of the solutions, capturing and documenting requirements
Provide essential operation and administrative support to the Quality Control Team, ensuring the laboratory environment remains organised, compliant, and fully stocked.
Compensation
Eisai offers a competitive salary and excellent wider benefits package
Responsibilities
Maintain a clean, organised, and compliant laboratory environment in line with GMP expectations
Perform routine housekeeping tasks including bench cleaning, waste disposal and glassware washing
Conduct routine equipment status check, documentation check and general lab readiness check
Monitor and maintain inventory of chemicals, reagents, consumables, PPE, and general lab supplies
Perform regular stock checks and update inventory records
IT Quality Specialist responsible for validation and quality activities for computerized systems in Roche’s Diagnostic division.
Compensation
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Responsibilities
Coordinate and advise on all validation activities on a global/organizational level
Author and review various validation documentation and deliverables
Act as a CSV subject matter expert on project teams
Support system audit inspection readiness
Lead and author Computerized System Periodic Reviews
Requirements
Bachelor’s degree in science/engineering/computer science
Nice to have: Agile software development
Nice to have: Scrum
Nice to have: SAFe
Nice to have: Product Development Process for Medical Devices
Coordinate and advise on all validation activities on a global/organizational level for each assigned system/project, author and review validation documentation, support system audit inspection readiness, and lead Computerized System Periodic Reviews.
Compensation
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Responsibilities
Coordinate and advise on all validation activities on a global/organizational level
Author and review various validation documentation and deliverables
Support system audit inspection readiness
Lead and author Computerized System Periodic Reviews
Assess changes to determine potential impact to the validated state of the computerized system
Requirements
Bachelor’s degree in science/engineering/computer science
Nice to have: Agile software development methodologies (Scrum and/or SAFe)
Nice to have: Product Development Process (PDP) for Medical Devices
Owns the technical integrity, standardization, and long-term health of the PharmaSuite solution that underpins the Next Generation Manufacturing Execution System.
Compensation
$144,000 - $231,000
Responsibilities
Drive standardization of manufacturing processes across sites
Define and maintain the global MES template
Partner with Technical Services & Manufacturing Technology, Process Engineering, Operations and Quality
Evaluate site requests for deviation from the standard
Establish and sustain the standards for Master Batch Record development
Requirements
Bachelor's degree in IT, Computer Science, Engineering, or equivalent
Support lifecycle management, qualification, and compliance of temperature-controlled equipment and analytical laboratory instrumentation at the Swiftwater, PA site.
Responsibilities
Execute and support temperature mapping and qualification of Controlled Temperature Units (CTUs)
Perform CTU temperature mapping studies using Ellab data loggers
Support development, review, and execution of CTU mapping and qualification protocols
Evaluate mapping data against approved specifications
Support IQ/OQ/PQ activities associated with CTUs
Requirements
Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
Nice to have: 3+ years of experience supporting CTU qualification
Nice to have: Hands-on CTU mapping and qualification experience
Nice to have: Experience performing temperature mapping studies using Ellab data loggers
Nice to have: Experience with logger configuration, placement, deployment, data retrieval, analysis, and troubleshooting
Business AnalystNewExclusively Remote · Remote, South Africa
MES Specialist – (eBR) DeveloperNewInteldot · Manati, Puerto Rico
IT Quality SpecialistNewRoche · Pleasanton, US
MES Systems Engineering - Sr. PrincipalLilly · Indianapolis, US