6505 - Validation Engineer / CQV Engineer - Change Control & Deviations

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 (Scientists, Quality) to ensure timely and compliant change implementation
• Support execution of change control deliverables, which could include tracking/ updating to documentation
• CQV & Compliance Support
• Analytical Development
• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support impact assessments and execution activities related to changes
• Review and approve technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes
• Cross-Functional Collaboration
• Interface with Analytics, Quality Assurance, 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 Chemistry, Engineering, Life Sciences, or related field
• 1-3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry
• Strong experience with:
• Change control systems
• cGMP and GDP environments
• Familiarity with analytical testing and Chemistry is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ)
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities
• Onsite job requirement in Indianapolis, IN

Pay

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range.

National (US) Range: $69,300 USD - $95,358 USD

Benefits

• 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
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Company Culture

• 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

Contact Information

• Verista is an equal opportunity employer
• For more information about our company, please visit us at Verista.com