6321 - Validation Engineer / CQV Engineer - Change Control & Deviations

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• 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

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes


• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact


• Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation


• Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)

Deviation Management

• Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)


• Ensure deviations are thoroughly documented, investigated, and closed within required timelines


• Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations

CQV & Compliance Support

• Maintain alignment with cGMP and Good Documentation Practices (GDP)


• Support validation impact assessments and execution activities related to changes


• Review and approve validation and technical documentation as required


• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams 


• Support continuous improvement initiatives related to quality systems and CQV processes


• Communicate project status, risks, and issues to stakeholders

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field


• 3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry


• Strong experience with:
  
  
  
  • Change control systems
  
  
  • Deviation investigations and root cause analysis
  
  
  • cGMP and GDP environments
  
  
  
  


• Familiarity with device assembly/packaging operations is highly preferred


• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus


• Strong technical writing and documentation skills


• Excellent communication and cross-functional collaboration abilities


• Onsite job requirement in Indianapolis, IN

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture


• Competitive pay plus performance-based incentive programs


• Company-paid Life, Short-Term, and Long-Term Disability Insurance.


• Medical, Dental & Vision insurances


• FSA, DCARE, Commuter Benefits


• Supplemental Life, Hospital, Critical Illness and Legal Insurance


• Health Savings Account


• 401(k) Retirement Plan (Employer Matching benefit)


• Paid Time Off (Rollover Option) and Holidays


• As Needed Sick Time


• Tuition Reimbursement


• Team Social Activities (We have fun!)


• Employee Recognition


• Employee Referral Program


• Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com