LL01-250919 Manufacturing Execution Systems Validation Specialist (NC)
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Job Location:
Morrisville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
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.
Qualifications
- Bachelors degree in Engineering Computer Science Life Sciences or related field. Advanced degree preferred.
- 710 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.
Preferred Skills
- 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.
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
