6097 - Senior CQV Engineer / Senior Validation Engineer

The role

The Senior CQV Engineer provides engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems. This role involves authoring documentation, troubleshooting technical issues, and coordinating with various project stakeholders.

What you will do

• Provide engineering and CQV support for manufacturing equipment and systems.
• Serve as a technical resource for equipment-related issues.
• Review engineering drawings and technical documentation.
• Support equipment design reviews.
• Coordinate with equipment vendors, contractors, and project stakeholders.
• Support and execute equipment startup, commissioning, troubleshooting, and qualification activities.
• Identify equipment and system issues and work with teams to drive resolution.
• Support FAT, SAT, commissioning, and qualification activities.
• Author, review, and revise CQV and engineering documentation.
• Manage assigned engineering/CQV activities against project schedules.

Required qualifications

• 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufact
• Strong understanding of manufacturing equipment and equipment systems.
• Demonstrated project engineering experience supporting equipment installation, startup, commissioning, or qualification.
• Experience working directly with equipment vendors, engineering teams, manufacturing personnel, and Quality.
• Working knowledge of CQV lifecycle activities, including FAT, SAT, commissioning, IQ, OQ, and PQ.
• Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
• Ability to author clear and technically accurate engineering and CQV documentation.
• Strong troubleshooting and problem-solving skills.
• Understanding of cGMP requirements and Good Documentation Practices.
• Strong communication, organizational, and project coordination skills.
• Ability to work independently while effectively collaborating within multidisciplinary project teams.
• Onsite work requirement in Bloomington, IN.

Nice to have

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline

Benefits

• High growth potential and fast-paced organization
• 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

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 to empower growth and innovation within the scientific community.