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 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 (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 withcGMP 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, , 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 Chemistry, Engineering, Life Sciences, or related field
- 1-3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry - Entry-level candidates encouraged to apply
- 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) is a plus
- Strong technical writing and documentation skills
- Excellent communication and cross-functional collaboration abilities
- Onsite job requirement in Indianapolis, IN
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. This salary range is subject to change and may be modified in the future.National (US) Range
$69,300-$95,358 USD
BenefitsWhy 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
