Computer System Validation Engineer

Harrisburg, PA - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

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 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