6590 - CQV Engineer - Change Control

The role

The CQV Engineer will support change control activities to maintain compliance and support quality systems. This role ensures manufacturing changes are assessed, documented, and executed in a regulated cGMP environment.

What you will do

• 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 to ensure timely and compliant change implementation
• Support execution of change control deliverables
• 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
• Interface with Analytics, Quality Assurance, and Engineering teams
• Support continuous improvement initiatives related to quality systems and CQV processes

Required qualifications

• 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
• Experience with change control systems
• Experience with cGMP and GDP environments
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities

Nice to have

• Familiarity with analytical testing and Chemistry
• Experience supporting validation lifecycle activities (IQ/OQ/PQ)

Benefits

• 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
• Employee Recognition

About the company

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The company provides innovative solutions and services that empower informed decision-making.