Senior Validation Engineer
CAI · Carmel, IN · 2 wk ago
On-siteQuality AssuranceFull-time
About the Role
CAI is seeking a professional to join our team, focusing on Commissioning, Qualification, and Validation (CQV) activities in the Pharmaceutical/Life Sciences industry. This role emphasizes safety, project coordination, and compliance with industry standards.
Responsibilities
- CQV Execution & Safety: Perform CQV activities with a strong focus on safety, aligning with project schedules, and track progress.
- Documentation & Compliance: Support the generation and review of C&Q procedures, revise qualification-related documents, and assist with CQV review and equipment design qualification.
- Project Planning & Coordination: Support planning of commissioning spares and consumables, allocate project resources, and coordinate logistics during CQV execution.
- Testing & Vendor Management: Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities, and coordinate with contractors and vendors.
Qualifications
- 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 opportunities, identifies innovative solutions, and anticipates market needs.
- Satisfy the Customer: Understands client needs, develops exceeding solutions, and ensures satisfaction.
- Plan for Success: Aligns strategies with plans, allocates resources, and anticipates risks.
- Pursue Execution: Prioritizes initiatives, holds accountability, and removes obstacles.
- Tailor Communication: Communicates clearly and adjusts messaging to suit audiences.
- Build Partnerships: Builds networks, promotes collaboration, and involves stakeholders.
- Influence Others: Builds support, gains buy-in, and encourages innovation.
- Develop Self And Others: Develops skills, acts with integrity, and seeks opportunities.
Benefits
- Comprehensive Health Insurance coverage
- 24 days of Paid Time Off
- Company paid Life Insurance
- Company paid Long Term Disability
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.