6589 - Deviation Investigator / Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Deviation Investigator / CQV leads deviations investigations, root cause analysis, CAPA development, and change controls in the Pharma industry: 

• →Lead deviation and out-of-specification (OOS) investigations, applying structured root cause analysis methods to determine the root cause. 

• →Author deviation reports, and CAPA plans with clear, defensible rationale that meets data integrity (ALCOA+) standards and holds up to regulatory scrutiny. 

• →Draft CAPA plans that are risk-appropriate, measurable, and linked to verified root causes.

• Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.)
• 1-3 years' experience
• Some Pharma experience preferred
• Deviation investigation remediation and/or quality experience is a plus
• New college grads with internship experience encouraged to apply
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent technical writing skills
• Excellent organizational and time management skills
• Strong attention to detail
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Onsite requirement in Indianapolis, IN