MES Engineer PAS-X
MES Engineer PAS-X
Posted on :
09-08-2023
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Job Description
The Senior MES Engineer will provide strong technical leadership with the responsibility to:
- Support execution and support of both CAPEX and OPEX activities for client facing MES
- Lead development and integration of the MES with existing systems
- Support documentation efforts for equipment validation and operating procedures
Duties and Responsibilities:
- Produce and review project configuration software design, documentation, testing and execution practices against client requirements.
- Anticipate, recommend, and champion requirements that serve client s best interest
- Manage and troubleshoot MES infrastructure and architecture, including application, database, integration services, operating system, security, networking, backup and recovery, and business continuity plans.
- Change control identification, specification, planning, documentation, and execution in compliance with GxP and GAMP guidelines.
- Coordinate with different departments to review, update, and approve plans.
- Project Management awareness, problem solving, planning and commercial meeting participation.
- Conception, demonstration, and execution of solutions to address requirements and overcome platform and project constraints.
- Must have experience successfully interacting and working with customers at multiple levels of responsibility in a manufacturing or production environment.
- MES traceability error proofing system management.
- Lead troubleshooting efforts to analyze data and help drive key process related decisions.
Requirements
- Minimum 3 years experience with Werum/Korber PAS-X or strong expertise in MES platforms for the Biopharmaceutical industry.
- 5+ years of engineering experience.
- Minimum 3 years experience working in the pharmaceutical industry or a closely related field.
- Understanding and implementation of process batch record and reporting requirements including data integrity principles for the industry.
- Effective verbal and written communication skills.
- Strong ability to diagnose and troubleshoot technological or procedural issues.
- Working knowledge of PLC, DCS & ERP systems.
- Must be able to handle multiple tasks, have excellent attention to detail, and be willing and able to learn new technologies quickly.
Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for new and modified systems. Providing independent quality review and approval of system changes. Supporting and approving computerised systems investigations and test deviations. Ensuring consistent approach to qualification, change and deviation management across systems being implemented on the project. Providing timely and pro-active QA IT support and guidance to facilitate project timelines, including close collaboration with the technical and business units. Where required, engaging with QA IT teams from other sites and capital projects to standardise and align approach to computerised systems compliance. Experience: Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry. Working knowledge of relevant regulations and industry standards. Proven ability to meet timelines, prioritise tasks and engage with stakeholders. Excellent communication skills. Project management experience will be an advantage. DeltaV
Employment Type
Full Time
Key Skills
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