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Manufacturing Execution Systems Validation Specialist
2 weeks ago
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle.
Key Responsibilities
- Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment.
- Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports.
- Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant.
- Perform impact assessments and change control for system upgrades, patches, and enhancements.
- Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations.
- Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian).
- Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits.
- Mentor junior validation engineers and support knowledge transfer on CSV best practices.
- Contribute to continuous improvement of MES validation strategies, procedures, and templates.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred.
- 7-10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing.
- Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records).
- Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5.
- Experience in biologics manufacturing processes (cell culture, purification, fill/finish).
- Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians).
- Excellent technical writing and documentation skills.
- Strong communication, leadership, and problem-solving abilities.
- Experience in large-scale biotech/biologics start-up or tech transfer projects.
- Knowledge of data integrity principles and ALCOA+ requirements.
- Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat).
- Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches.
