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
$102,100 - $111,700 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
• ESOP/401K - 15% Company Contribution (US Only)
• 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. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
