CQV Engineer (LSNA-IN/VA)

About the role

As a Commissioning, Qualification, and Validation (CQV) Engineer, you’ll join our collaborative team providing CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. You’ll be accountable for developing CQV planning documents to manage CQV projects, generating and executing CQV protocols using Good Documentation Practices (GDPs), investigating and resolving protocol exceptions or discrepancies, developing technical reports and CQV summary reports, and starting up equipment in a safe and effective manner. You’ll also perform risk assessments and impact assessments, read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs), develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.

Requirements

• Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering or equivalent years of experience in lieu of degree
• CQV experience in the Life Sciences or advanced manufacturing industry
• Understanding of Good Manufacturing Practices (GMPs)
• Proficient with Microsoft Office – Word, Excel, PowerPoint, Project
• Flexibility and willingness to travel and work at various clients’ locations

Ideal qualifications

• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
• Knowledge of industry guidance ISPE Baseline Guide 5 Commissioning and Qualification
• ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
• ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
• ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011
• Six Sigma Certification

Location

This position will be onsite at either our Lebanon, Indiana or Richmond, Virginia site locations.

Benefits

• Medical, dental, vision, and basic life insurance
• 401(k) plan with company stock purchase option at a discount
• Deferred compensation plan or Executive Deferral Plan (for eligible employees)
• Unlimited U.S. Personalized Paid Time Off (PPTO) policy for full-time salaried/exempt employees
• Seven paid holidays and caregiver leave
• Additional rewards for certain roles, including merit increases, performance discretionary bonus, and stock

Pay

The base salary range for this position is $69,500.00 to $115,000.00. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.