6095 - CQV Engineer / Validation Engineer

Responsibilities

• 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.
• Cookordination testing activities with Engineering, Manufacturing, Quality, and Vendor teams.
• 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.
• Aid 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.
• 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

Benefits

• 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
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement