5-7 years of experience in validation, calibration, or CQV within pharmaceuticals or regulated environments
In-depth knowledge of GMP and 21 CFR Part 11 compliance
Demonstrated expertise in Computerized System Validation (CSV)
Hands-on proficiency with IQ/OQ/PQ validation processes
Excellent problem-solving and communication skills
Experience in cross-functional team collaboration
Responsibilities
Perform validation and calibration for pharmaceutical manufacturing and sterile processing equipment
Ensure compliance with GMP and 21 CFR Part 11
Develop and execute Master Validation Plans, SOPs, and validation protocols
Conduct equipment qualification activities including IQ/OQ/PQ
Perform instrument calibration for various equipment types
Support validation of sterilization and cleaning systems
Execute validation projects adhering to timelines and KPIs
Collaborate with teams to troubleshoot and resolve validation issues
Implement a risk-based validation approach
Benefits
Comprehensive health insurance
401(k) retirement plan
Professional development opportunities
Flexible working hours
Paid time off and holidays
Supportive team environment
Full Job Description
Job Summary:
We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment.
This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV).
Roles & Responsibilities:
Perform validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment
Ensure compliance with GMP and 21 CFR Part 11 standards
Develop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization procedures
Conduct equipment qualification activities (IQ/OQ/PQ) and ongoing performance monitoring
Perform instrument calibration for equipment such as dual display light meters, open air shakers, and various scales
Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts washers, and autoclaves
Execute validation projects, ensuring timelines, budgets, and KPIs are met
Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve validation discrepancies
Apply a risk-based approach to validation to ensure compliance and operational efficiency
Coordinate resources and activities for complex validation and CSV initiatives
Experience:
Experience in validation, calibration, or CQV within a pharmaceutical or regulated environment
Strong knowledge of GMP and 21 CFR Part 11 compliance
Proven experience with Computerized System Validation (CSV)
Hands-on experience with IQ/OQ/PQ and validation lifecycle documentation
Strong problem-solving, communication, and cross-functional collaboration skills
