6095 - CQV Engineer / Validation Engineer
Job Description
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
CQV / Validation Engineer Responsibilities:
Commissioning, Qualification & Validation (CQV)
- Execute commissioning, qualification, and validation activities for manufacturing equipment, utilities, facilities, and process systems.
- Author, review, and execute validation lifecycle documentation including:
- Commissioning Protocols
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- Validation Summary Reports
- Traceability Matrices
- Risk Assessments
- Support startup and operational readiness activities for new production equipment and manufacturing systems.
- Perform field verification activities, walkdowns, and documentation reviews to ensure systems are installed and functioning according to design requirements.
- Coordinate testing activities with Engineering, Manufacturing, Quality, and Vendor teams.
Manufacturing & Technical Support
- Support qualification of production equipment used in pharmaceutical manufacturing operations.
- Troubleshoot qualification and validation issues encountered during equipment startup and testing.
- Review engineering documentation including P&IDs, equipment specifications, drawings, and vendor documentation.
- Ensure equipment and systems meet GMP, regulatory, and internal quality requirements.
- Assist in identifying and resolving deviations, discrepancies, and validation-related issues.
Compliance & Documentation
- Ensure all validation activities are executed in accordance with current GMP regulations and company procedures.
- Maintain clear, accurate, and compliant validation documentation.
- Support change controls, deviations, CAPAs, and validation impact assessments as required.
- Participate in audits and inspections by providing validation subject matter expertise.
Lead Validation Engineer (Additional Responsibilities)
- Provide technical leadership and mentorship to validation team members.
- Coordinate validation deliverables and execution schedules across multiple systems and workstreams.
- Interface with project leadership to communicate risks, resource needs, and project status.
- Review and approve validation documentation prepared by junior team members.
- Drive resolution of complex qualification and startup challenges.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 3+ years of CQV, Validation, Commissioning, or Qualification experience (Validation Engineer).
- 7+ years of CQV, Validation, or Pharmaceutical Manufacturing experience (Lead Validation Engineer).
- Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments.
- Strong understanding of validation lifecycle principles and documentation requirements.
- Experience authoring and executing IQ/OQ/PQ protocols.
- Ability to work onsite in Bloomington, Indiana.
Preferred
- Experience supporting startup of new manufacturing lines, facilities, or capital projects.
- Experience within pharmaceutical manufacturing, sterile manufacturing, biologics, or contract manufacturing environments.
- Familiarity with ISPE, FDA, EU GMP, and GAMP guidance.
- Experience managing deviations, change controls, and risk assessments.
- Strong technical writing and documentation skills.
Key Skills
- Commissioning & Qualification (CQV)
- Equipment Validation
- Manufacturing Systems
- IQ / OQ / PQ Execution
- GMP Compliance
- Technical Writing
- Risk Assessments
- Deviation Management
- Change Control
- Cross-Functional Collaboration
- Startup & Operational Readiness
- Problem Solving & Troubleshooting
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.
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