CSV Engineer
CSV Engineer
Posted on :
02-05-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
02-05-2025
Job Description
Job description:
Were seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of handson experience in the pharma/biotech industry. Youll partner with QA Business and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions.
Responsibilities:
Were seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of handson experience in the pharma/biotech industry. Youll partner with QA Business and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions.
Responsibilities:
- Lead endtoend validation activities including test preparation authoring of IQ/System/UAT scripts Dry Run test data setup environment readiness test facilitation and postexecution review.
- Develop and execute validation deliverables including URS Risk Assessments IQ/OQ/PQ and Summary Reports.
- Ensure all activities comply with 21 CFR Part 11 GAMP 5 and internal SOPs.
- Author Review and Approve validation documentation lifecycle: Validation & Test Plan requirement Test Scripts Assessment documents and Summary Reports.
- Validate electronic batch records (EBR) MES recipes interfaces and integration with systems such as SAP Oracle LIMS CMMS GPS and EDMS.
- Collaborate with Business Owners QA and IT to align on requirements and ensure CSV deliverables are compliant and audit ready.
- Coordinate recipe configuration master data setup and validation in Syncade MES.
- Ensure validation practices meet GAMP 5 CSA 21 CFR Part 11 and ALCOA data integrity principles.
- Bachelors degree in computer science Information Systems or a related engineering discipline.
- Minimum 3 years of experience in pharma/biotech with focus on IT Validation and Quality Assurance & Compliance.
- Experience with MES platforms (Syncade preferred) and electronic batch records (EBR).
- Familiar with tools such as ALM ServiceNow SQL databases and document management systems.
- Knowledge of shop floor operations process automation and manufacturing environments are preferable.
- Proven ability to manage competing priorities with a flexible workstyle and consistently deliver efficient compliant results in fastpaced crossfunctional environments.
- Experienced in crossfunctional communication with the ability to interpret and convey business and IT need to Validation comfortable interacting with QA business and technical teams.
- Deep understanding of MES Syncade & Recipes testing phases (IQ System Testing Recipe UAT).
- Familiarity with cGMP GAMP SDLC 21 CFR Part 11 and Good Documentation Practices (GDP).
- Demonstrated ability to independently lead system validation efforts across multiple stakeholder groups.
- Must Have 4 years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments with strong knowledge of GAMP 5 21 CFR Part 11 and Computer Software Assurance (CSA) principles.
- 3 years of handson MES experience with Emerson Syncade including recipe validation EBR testing and interface verification with systems such as SAP LIMS and Oracle.
- 2 years of project management experience demonstrating the ability to prioritize urgent tasks manage competing deadlines and adapt effectively within dynamic crossfunctional teams.
- 3 years of advanced experience with ALM ServiceNow SQL databases and document management systems (e.g. Veeva BMSDocs) supporting testing issue tracking and controlled documentation.
Employment Type
Full Time
Key Skills
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