6097 - Senior CQV Engineer / Senior Validation Engineer

Verista; Bloomington (IN); On-site; USD 79,000 - 123,000; Full time

Benefits offered by this job

Competitive pay

Health insurance

401(k) with matching

Tuition Reimbursement

Paid time off

Holidays

Parental leave

Disability insurance

Life insurance

Career growth opportunities

Job summary

Verista in Bloomington, IN is seeking a Senior CQV Engineer to support commissioning, qualification, and validation of manufacturing equipment and systems in a regulated life sciences setting. You will review drawings, documents, and participate with vendors and cross-functional teams.

The role requires 5+ years of experience, CQV lifecycle knowledge (FAT/SAT/IQ/OQ/PQ), strong problem-solving and communication, and on-site work in Bloomington.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field or equivalent industry experience.
• 5+ years in engineering, commissioning, qualification, validation, or equipment implementation in regulated manufacturing.
• Ability to read engineering drawings, P&IDs, and equipment specs.
• Experience with FAT/SAT/IQ/OQ/PQ and CQV lifecycle activities.
• Strong communication, organizational, and collaboration skills.

Responsibilities

• Provide CQV support for commissioning, qualification, and validation of manufacturing equipment and systems.
• Review drawings, specifications, datasheets, P&IDs, and vendor documentation.
• Coordinate with vendors, Engineering, Manufacturing, Automation, and Quality teams.
• Lead or support startup, commissioning, troubleshooting, and qualification activities.
• Document URS, commissioning protocols, IQ/OQ/PQ reports, risk assessments, and turnover documentation.
• Ensure activities align with project requirements, site procedures, and cGMP expectations.
• Support field installation, startup, testing, and issue resolution.

Skills

CQV lifecycle

Vendor coordination

Documentation drafting

Field support

Problem solving

Education

Bachelor’s degree in Engineering/Life Sciences

Job 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

Senior CQV Engineer Responsibilities:

• Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
• Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
• Serve as a technical resource for equipment-related issues throughout design, installation, commissioning, startup, and qualification.
• Review engineering drawings and technical documentation, including P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
• Support equipment design reviews and provide input regarding functionality, maintainability, operability, and qualification requirements.
• Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and other project stakeholders.
• Support and/or execute equipment startup, commissioning, troubleshooting, and qualification activities.
• Identify equipment and system issues and work with project teams and vendors to drive issues through resolution.
• Support FAT, SAT, commissioning, and qualification activities as required.
• Author, review, and revise CQV and engineering documentation, including:
• User Requirements Specifications (URS)
• Commissioning protocols
• IQ/OQ/PQ protocols and reports
• Risk assessments
• Traceability documentation
• Engineering studies
• Deviations and discrepancy documentation
• Turnover and closeout documentation
• Ensure commissioning and qualification activities are appropriately documented and executed in accordance with project requirements, site procedures, and cGMP expectations.
• Manage assigned engineering/CQV activities against project schedules and communicate risks, issues, and progress to project leadership.
• Provide hands-on support in the field during equipment installation, startup, testing, and qualification.
• Support investigation and resolution of technical issues encountered during commissioning and qualification.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
• Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
• Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
• 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 with the ability to identify and resolve equipment-related issues.
• 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.

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. Verista is an equal opportunity employer.

National (US) Range: $78,925 USD - $122,603 USD

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

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