Senior Validation Engineer

CAI; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Comprehensive Health Insurance coverage

24 days of Paid Time Off

ESOP/401K - 15% Company Contribution

Company paid Life Insurance

Company paid Long Term Disability

Job summary

A leading company in life sciences is seeking a professional for CQV Execution and Safety. Responsibilities include performing commissioning, qualification, and validation activities, ensuring compliance with documentation, and managing project planning. The ideal candidate will have a Bachelor's degree in Engineering or Life Sciences, alongside 3+ years of experience in a GMP environment. The position offers comprehensive health insurance, paid time off, and a 401K plan.

Qualifications

• 3+ years of related experience in the Pharmaceutical/Life Sciences industry.
• Essential experience in a GMP (Good Manufacturing Practice) environment.
• Willingness and flexibility to travel throughout the U.S. and potentially internationally.

Responsibilities

• Perform CQV activities with a strong focus on safety.
• Support the generation and review of C&Q procedures.
• Coordinate support and logistics during CQV execution.
• Support execution of design reviews, commissioning activities.

Skills

Outstanding oral and written communication skills

Strong problem-solving abilities

Customer-focused mindset

Ability to work in GMP environments

Education

Bachelor's degree in Engineering, Chemistry, or Life Sciences

Job description

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

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

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.

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).