Key Responsibilities
CQV Execution & Safety
- Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety
- Deliver C&Q activities in alignment with project schedules
- Track and report progress of CQV efforts
Documentation & Compliance
- Support the generation and review of C&Q procedures for client projects
- Review and revise qualification-related documents, including SOPs, master plans, and execution plans
- Assist with CQV review and qualification of equipment design
Project Planning & Coordination
- Support planning of commissioning spares and consumables
- Allocate project resources for efficient execution
- Coordinate support and logistics during CQV execution
Testing & Vendor Management
- Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities
- Coordinate with project contractors and equipment vendors to execute required testing
Qualifications and Experience
- Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
- 3+ years of related experience in the Pharmaceutical/Life Sciences industry
- Essential experience in a GMP (Good Manufacturing Practice) environment
- Outstanding oral and written communication skills
- Strong problem-solving abilities
- Customer-focused mindset
- Willingness and flexibility to travel throughout the U.S. and potentially internationally
Critical Competencies
Influence Strategy
- Evaluates and pursues opportunities based on organizational strategy
- Identifies innovative solutions with strategic impact
- Anticipates emerging customer and market needs
Satisfy the Customer
- Understands and anticipates client needs
- Develops solutions that exceed expectations
- Actively follows up to ensure satisfaction and loyalty
Plan for Success
- Aligns business strategies with actionable plans
- Allocates resources effectively
- Anticipates risks and builds contingency plans
Pursue Execution
- Prioritizes initiatives to ensure goal achievement
- Holds self and team accountable
- Proactively removes obstacles
Tailor Communication
- Communicates clearly, concisely, and professionally
- Adjusts messaging to suit audience
- Explains technical concepts across all levels
Build Partnerships
- Builds strong networks across teams and disciplines
- Promotes collaboration and removes silos
- Involves stakeholders in decision-making
Influence Others
- Builds support through sound reasoning
- Gains buy-in from decision makers
- Encourages innovation and better outcomes
Develop Self and Others
- Continuously develops relationship and leadership skills
- Acts with integrity and models company values
- Seeks out breakthrough opportunities
#LI-MV1
$87,152 - $94,600 a year
Average base salary range - not including benefits, and potential overtime and/or 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.
