Key Responsibilities
1. Technical Responsibilities
- Develop documentation for CQV activities
- Write and execute protocols (field verification)
- Develop summary reports at client sites
2. Areas of Focus
- Pharmaceutical facilities
- Utilities
- Equipment
3. Project & Team Management
- Plan and coordinate work
- Direct small teams in document development and/or execution
Qualifications and Experience
- Bachelor's degree in a science or engineering field (or equivalent experience)
- 2-4 years' experience in commissioning and qualification in a regulated industry
- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus
- Preferred experience in:
- Facilities and equipment startup
- Walk-downs and troubleshooting
- Utilities (WFI, RO, HVAC)
- Upstream/downstream processing
- Purification, recovery
- Building automation
- Pharmaceutical manufacturing processes
Critical Competencies
Influence Strategy
- Pursues initiatives aligned with organizational strategy
- Identifies strategic, innovative solutions
- Anticipates emerging customer/market needs
Satisfy the Customer
- Understands and anticipates customer needs
- Delivers high-quality solutions and service
- Proactively maintains satisfaction and loyalty
Plan for Success
- Aligns business strategies with actionable plans
- Anticipates risks and builds contingency plans
- Secures resources for goal achievement
Pursue Execution
- Prioritizes time and resources effectively
- Holds self and others accountable
- Acts to overcome obstacles and improve quality
Tailor Communication
- Communicates clearly and professionally
- Adjusts style to fit the audience
- Explains technical concepts effectively
Build Partnerships
- Builds networks across functions
- Encourages collaboration and breaks down silos
- Involves stakeholders in decisions
Influence Others
- Builds support with sound rationale
- Gains buy-in from decision makers
- Encourages innovative thinking
Develop Self and Others
- Enhances interpersonal relationships
- Models integrity and company values
- Seeks out growth and breakthrough opportunities
#LI-MV1
$75,000 - $90,000 a year
Average base salary range - not including benefits, and potential overtime and Cost of Living Adjustment.
CAI Benefits:
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability
This job description is not all inclusive and you may be asked to do other duties.
