6097 - Senior CQV Engineer / Senior Validation Engineer

United States·Bloomingtonsenior

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Provide engineering and CQV support for the implementation, modification, commissioning, and

Technical Tools

QA & TestingValidation Engineer

Description

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

Responsibilities

~2 min read

→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

~2 min read

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—$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

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