CQV Engineer II

Role Summary

The CQV Engineer II will be responsible for writing, execution, and summary of commissioning, qualification, and verification protocols related to local and enterprise based computerized systems, laboratory instruments, manufacturing equipment, and facility and utility-based systems. They will support the development of validation specifications, assessments and master plans. They will prepare and complete periodic reviews and requalifications in a timely manner. All work to be conducted according to governing SOPs and cGMPs (current Good Manufacturing Practices).

Responsibilities

• Support activities related to commissioning, qualification, and verification of facility, utilities, laboratory instruments, manufacturing equipment, and computerized systems
• Lead the creation and revision of validation assessments, including GAMP and electronic records and signatures assessments
• Take part in the development and revision of validation specifications including URS, FRS, CS, and DS, as well as Trace Matrices
• Assist in the development of project or system specific Validation Plans
• Write, execute, and summarize commissioning, qualification, and verification protocols
• Identify and support the resolution of protocol deviations noted during protocol execution and review
• Assist in root cause analysis related to QA Deviations / Non-conformance events
• Adheres to periodic review and requalification schedule for systems per procedure and established plans
• Revise internal and external departmental procedures based on previously obtained CQV data
• Present findings and results from completed CQV deliverables in internal and external audits specific to work which was performed firsthand
• Represent the CQV team in internal meetings
• Other Duties as assigned

Qualifications

• 3 years of direct commissioning, qualification, validation, and/or verification experience, required
• 4+ years of pharmaceutical / biotech experience preferred
• Bachelor‚Äôs degree, required, preferably in Engineering, mathematics, or a scientific field
• Specialized or strong experiences in one of the following areas:
  • Site or enterprise based computerized systems
  • Laboratory instruments
  • Manufacturing equipment
  • Automation systems
  • Facility and utilities
  • Periodic Reviews
• Strong working knowledge of good documentation practices and FDA, EudraLex, and other regulatory guidance, preferred
• Ability to lift up to 20 pounds, required
• Willingness to regularly, predictably, and reliably perform required functions at work, including occasional work outside typical office hours and weekends
• Excellent communication and interpersonal skills
• Positive roll-up-the-sleeves attitude and optimistic outlook
• Ability to work in a fast-paced team environment with fluctuating priorities and cross-functional collaboration
• Excellent organizational and time management skills; ability to set priorities
• High flexibility and adaptability
• Self-motivated and organized critical thinker with strong interpersonal and business communication skills
• Represents the organization in a positive and professional manner

Skills

• Validation planning and execution
• Documentation control and audits
• Root cause analysis
• Cross-functional collaboration
• Regulatory knowledge (FDA, EudraLex)
• System validation (URS/FS/CS/DS, Trace Matrices)

Education

• Bachelor‚Äôs degree in Engineering, mathematics, or a scientific field

Additional Requirements

• None beyond listed qualifications