What are the responsibilities and job description for the Project Manager position at United Consulting Hub?
Job Title: Project Manager – CQV
Location: Texas
Employment Type: W2
Job Summary
We are seeking an experienced Project Manager – CQV (Commissioning, Qualification & Validation) to lead and coordinate CQV activities for pharmaceutical, biotechnology, and medical device manufacturing projects.
The ideal candidate will oversee project planning, execution, resource coordination, and validation deliverables while ensuring compliance with GMP, FDA, and industry standards.
Key Responsibilities
- Lead CQV projects from planning through execution and closeout
- Manage project schedules, budgets, resources, and deliverables
- Coordinate commissioning and qualification activities for equipment, utilities, facilities, and systems
- Oversee execution of:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Collaborate with Engineering, Validation, Quality, Manufacturing, and Operations teams
- Monitor project risks, issues, and mitigation plans
- Ensure compliance with GMP, FDA, ISPE, and validation lifecycle requirements
- Review and approve validation protocols, reports, and project documentation
- Provide regular project updates to stakeholders and leadership
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related technical field
- 4 years of experience in CQV, Validation, Engineering, or Project Management
- Strong experience managing pharmaceutical, biotech, or medical device projects
- Knowledge of:
- Commissioning & Qualification
- Validation Lifecycle
- GMP/cGMP Regulations
- FDA Compliance
- Excellent project management, leadership, and communication skills
Preferred Skills
- Experience with large-scale facility startup or expansion projects
- Familiarity with Kneat, ValGenesis, or other validation management systems
- PMP Certification preferred
- Experience with clean utilities, process equipment, and manufacturing system