Product Engineer Jobot
Wampum, PA3 days ago
- $70,000–$95,000 Per Year
Want to know if you’re a fit?
Upload your resume and let our AI show you.
Upload your resume and let our AI show you.
Skills
- Biologyunmatched
- Biostatisticsunmatched
- Clinical Practices/Protocolsunmatched
- Code of Federal Regulationsunmatched
- Computer Skillsunmatched
- Computer Softwareunmatched
- Computer Systemsunmatched
- Consultingunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- GxPunmatched
- ISO 9001unmatched
- ITIL (IT Infrastructure Library)unmatched
- Laboratory Information Management System (LIMS)unmatched
- Laboratory Notebookunmatched
- Labwareunmatched
- Manufacturing Requirementsunmatched
- Medical Affairsunmatched
- Pharmacovigilanceunmatched
- Regulationsunmatched
- Riskunmatched
- SAPunmatched
- Sarbanes-Oxley Act (SOX)unmatched
- Standard Operating Procedures (SOP)unmatched
- System Validationunmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Validation Testingunmatched
- Writing Skillsunmatched
Description
Job Description:
- Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.
- Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL.
- Ensure audit and inspection readiness.
- Conduct periodic reviews, access roster reviews, and audit trail reviews.
- Manage deviations, CAPA processes, SOP, and policy compliance.
- Author and review URS / FS documents, validation protocols, validation plans & reports, and final summary reports.
- Perform risk-based validation and testing aligned with CSA (Computer Software Assurance).
- Support validation lifecycle from planning to execution and closure.
- Work with platforms such as Veeva Vault Suite, LabWare LIMS, SAP (GxP modules), and BIOVIA Electronic Lab Notebook.
- Collaborate with teams across Biostatistics, Clinical & Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Manufacturing, Quality, and TechOps.
- 8 10 years of experience in Computer System Validation (CSV).
- Strong knowledge of GxP regulations, validation frameworks, GAMP 5, and CSA principles.
- Experience with CAPA, deviation management, SOP, and policy compliance.
- Strong documentation and validation lifecycle experience.
- Good understanding of life sciences domain processes.
Numbers & Facts
| Location | New Wilmington, PA |
Similar Jobs
- New!
Mechanical Engineer Integrity Technical Services
Salem, OH30+ days ago- $80,000–$105,000 Per Year
- Full-time
- Employee
Principal Electrical Engineer- CES Constellation Energy
Evans City, PA19 days ago- $118,800–$132,000
- New!
CapEx Project Engineer Ecolab Inc.
Ellwood City, PA1 day ago- $101,400–$152,100 Per Year
- New!
Mechanical Project Engineer Axelon
Cochranton, PA5 days ago- $51–$59 Per Hour