Computer System Validation Engineer
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Job Location:
Des Moines, IA - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Pennsylvania United States
Position Overview
We are looking for an experienced CSV Engineer to support the validation and lifecycle management of computerized systems in GMP-regulated manufacturing environments. The role bridges automation IT and quality compliance ensuring validated systems maintain data integrity regulatory compliance and operational excellence.
Key Responsibilities
- Lead and execute Computer System Validation (CSV) activities in line with GxP FDA and EU GMP requirements
- Develop review and manage validation documentation including URS FS DS IQ/OQ/PQ protocols risk assessments and traceability matrices
- Support commissioning and qualification of Building Management Systems (BMS) and Environmental Management Systems (EMS)
- Validate and maintain DeltaV hardware applications and software environments
- Oversee MES validation for Production and Quality modules
- Integrate and validate industrial data platforms such as HighByte and Kepware
- Support automation and scheduling platforms (Dynamic Equipment Scheduler Green Button Go)
- Ensure validated state compliance for asset management and change control platforms (OctoPlant)
- Contribute to validation for advanced manufacturing systems like Cellular Origins Constellation
- Collaborate cross-functionally with QA IT Engineering and Operations teams
Required Qualifications
- Bachelors degree in Engineering Computer Science or related field
- Proven CSV experience in pharmaceutical biotech or advanced manufacturing environments
- Strong knowledge of GMP GAMP 5 21 CFR Part 11 and EU Annex 11
- Hands-on experience with DeltaV systems (hardware application software)
- Experience validating MES Production and Quality modules
- Familiarity with industrial data integration OPC connectivity and automation scheduling tools
- Excellent documentation risk assessment and stakeholder communication skills
Preferred Qualifications
- Experience in cell therapy or highly automated manufacturing environments
- Strong understanding of data integrity principles and audit readiness
- Ability to manage multiple validation projects simultaneously
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
