CQV Engineer

Overview

Remote
On Site
Full Time

Skills

Regulatory Compliance
Documentation
Standard Operating Procedure
Pharmaceutics
Biotechnology
Management
Good Manufacturing Practice
Risk Assessment
Gap Analysis
Mentorship
Project Management
Communication

Job Details

Job Description:
  • We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries.
  • The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment.
Responsibilities:
  • Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical facilities and equipment.
  • Conduct risk assessments and gap analyses to identify potential compliance issues and develop strategies to mitigate them.
  • Lead and manage CQV project teams, including coordinating with internal and external stakeholders.
  • Ensure compliance with all relevant regulations and guidelines, including FDA, EMA, and ICH.
  • Generate and maintain CQV documentation, including protocols, reports, and standard operating procedures (SOPs).
  • Troubleshoot and resolve technical issues related to CQV activities.
  • Train and mentor junior CQV engineers and technicians.
  • Participate in client meetings and provide regular updates on project progress.
  • Continuously improve CQV processes and procedures to ensure efficiency and effectiveness.
Requirements:
  • Bachelor's degree in engineering or related field.
  • Minimum of 5 years of experience in CQV within the pharmaceutical or biotechnology industry.
  • Strong knowledge of cGMP regulations and guidelines.
  • Experience with commissioning, qualification, and validation of equipment and facilities.
  • Excellent project management skills and ability to lead and manage project teams.
  • Commissioning.
  • Qualification.
  • Validation.
  • cGMP regulations.
  • project management.
  • risk assessments.
  • gap analyses.
  • Communication.
  • interpersonal skills.
  • Troubleshooting.
  • Mentoring.
  • Excellent project management skills.
  • Strong communication and interpersonal skills.
  • bility to work independently and in a team environment.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.