CQV Engineer

Overview

On Site
Full Time

Skills

IQ
OQ
PQ
Risk Assessment
Adobe AIR
Distribution
Storage
System Integration
EP
HVAC
ISO 9000
Reporting
Test Scripts
Change Control
Presentations
Project Management
Manufacturing
Regulatory Affairs
Management
Budget
Life Sciences
Pharmaceutics
Biotechnology
Good Manufacturing Practice
GMP
Risk Management
FMEA
Hazard Analysis And Critical Control Points
Computerized System Validation
Regulatory Compliance
Statistics
Technical Writing
Documentation
Conflict Resolution
Problem Solving
Communication
Collaboration

Job Details

Responsibilities:
  • Lead CQV activities for new and modified filling lines, including isolator systems.
  • Develop and execute IQ, OQ, and PQ protocols for filling equipment such as vial washers,
  • dehydrogenation tunnels, filling machines, and capping systems.
  • Perform risk assessments (e.g., FMEA) for filling line modifications and qualifications.
  • Troubleshoot and resolve technical issues during qualification activities
  • Clean Utility System.
  • Manage CQV processes for clean utility systems, including purified water, Water for Injection
  • (WFI), clean steam, and compressed air.
  • Develop validation strategies for utility distribution systems and storage tanks.
  • Collaborate with automation teams on DeltaV system integration and validation.
  • Ensure compliance with relevant pharmacopeia standards (e.g., USP, EP) for water systems
  • Cleanroom Qualification.
  • Lead qualification efforts for cleanroom modifications and new installations.
  • Develop and execute protocols for HVAC system performance, including airflow studies and
  • particle counting.
  • Coordinate with environmental monitoring teams to establish and validate monitoring protocols.
  • Ensure compliance with ISO 14644 standards and GMP Annex 1 requirements.
  • Documentation and Reporting.
  • Generate comprehensive validation documentation, including protocols, test scripts, summary reports, and final qualification packages.
  • Maintain clear, detailed records of qualification activities and change control processes.
  • Prepare technical reports and presentations for management and regulatory bodies Project Management.
  • Collaborate with cross-functional teams, including engineering, manufacturing, quality.
  • ssurance, and regulatory affairs Manage project timelines, resources, and budgets for CQV activities.
  • Participate in FAT/SAT activities at equipment vendor sites and on-site
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
  • Minimum of 5 years of experience in CQV within the pharmaceutical or biotechnology industry.
  • In-depth knowledge of cGMP regulations, including EU GMP Annex 1 and FDA aseptic processing guidelines.
  • Extensive experience with qualification of filling lines, clean utilities, and cleanroom systems.
  • Proficiency in risk management methodologies (e.g., FMEA, HACCP).
  • Strong understanding of aseptic processing and sterilization techniques.
  • Experience with isolator technology and RABS (Restricted Access Barrier Systems).
  • Familiarity with computerized system validation and 21 CFR Part 11 compliance.
  • Knowledge of statistical analysis and sampling plans for qualification activities.
  • Proficiency in technical writing and documentation.
  • Strong problem-solving skills and ability to work independently.
  • Excellent communication and interpersonal skills for effective collaboration.
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