MaximaTek · 1 day ago
Computer System Validation
Wyoming, United States
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expMaximaTek partners with top-tier companies in the life sciences and manufacturing sectors, specializing in Quality and Compliance. They are seeking motivated individuals for Computer System Validation (CSV) and Equipment Validation positions, responsible for ensuring that computerized systems and manufacturing equipment meet regulatory requirements.
Management Consulting
Hiring Manager
Sai Teja Kothapally
Responsibilities
Documentation: Author and execute Validation Plans, Protocols (IQ/OQ/PQ), and Summary Reports
System Lifecycle: Oversee the validation of automated systems, PLC-based equipment, and enterprise software
Risk Management: Conduct GxP assessments and functional risk assessments to identify critical-to-quality parameters
Compliance: Ensure all activities adhere to ALCOA+ data integrity principles and current Good Manufacturing Practices (cGMP)
Qualification
Required
Bachelor's or Master's degree in Biomedical Engineering, Chemical Engineering, Computer Science, or a related technical field
0–5 years of experience in a regulated industry (Pharma/MedTech) or academic project experience related to quality systems
Strong understanding of the V-Model and GAMP 5 frameworks
Proficiency in writing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Knowledge of 21 CFR Part 11 (Electronic Records and Signatures)
Experience with Change Control and Deviation Management
Preferred
Familiarity with Laboratory Information Management Systems (LIMS) or MES
Knowledge of PLC/SCADA systems and automation validation
Experience with statistical tools (Minitab) and Root Cause Analysis (RCA)
Benefits
Targeted Placement: Direct marketing to our network of hiring managers in the Life Sciences and MedTech industries.
Validation Resume Rebuild: Optimization of your resume to highlight GxP knowledge and technical documentation skills.
Interview Coaching: Guidance on navigating quality-focused interviews and regulatory compliance case studies.
Company
MaximaTek
Maxima Technologies is a privately owned, leading professional IT services firm Based in Cheyenne, WY.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase