6095 - CQV Engineer / Validation Engineer

United States·Bloomingtonmid

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Commissioning,

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

~1 min read

→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

~1 min read

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.

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.

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.

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.

Nice to Have

~1 min read

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.

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.

National (US) Range

$87,780—$108,980 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