Senior Validation Engineer

CAI; Bloomington (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 life sciences firm is seeking a professional focused on Commissioning, Qualification, and Validation (CQV) execution with a strong safety emphasis. Candidates should possess a Bachelor's degree in Engineering, Chemistry, or Life Sciences and have over three years of relevant experience in the Pharmaceutical/Life Sciences industry. Key responsibilities include project planning, documentation compliance, and vendor management. The role requires excellent communication skills and the ability to travel across the U.S. and possibly internationally. Benefits include comprehensive health coverage and a generous PTO policy.

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 Commissioning, Qualification, and Validation (CQV) activities.
• Support the generation and review of C&Q procedures.
• Support planning of commissioning spares and consumables.

Skills

GMP experience

Outstanding communication skills

Problem-solving abilities

Customer-focused mindset

Flexibility to travel

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).