Jobs · Quality Assurance · Indiana

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.

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