Principal CQV Engineer: Biotech Solution Prep & Validation

Verista, Inc.; Apex (NC); On-site; USD 108,000 - 168,000; Full time

Benefits offered by this job

Competitive pay

Disability Insurance

Medical/Dental/Vision

401(k)

Paid Time Off

Tuition Reimbursement

Team Activities

Job summary

Verista in Apex, NC is seeking a Solution Preparation Principal CQV Engineer to lead commissioning, qualification and validation activities for solution preparation systems in biopharmaceutical manufacturing.

You will author and execute CQV documentation, ensure compliance with cGMP, support equipment startup and FAT/SAT, and collaborate with engineering, automation, QA, and manufacturing to deliver projects on time; onsite work in Apex, NC is required.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related technical field.
• 10+ years of role-specific experience.
• Experience supporting CQV activities within GMP-regulated pharma/biotech environments.
• Hands-on experience with solution preparation, buffer prep, or media prep systems.
• CQV lifecycle documentation (IQ/OQ/PQ) knowledge.

Responsibilities

• Support CQV activities for solution preparation systems used in biopharmaceutical manufacturing.
• Author, review, and execute CQV lifecycle documentation including IQ/OQ/PQ protocols and reports.
• Ensure validation documentation complies with cGMP regulations and internal quality procedures.
• Participate in system impact assessments, risk assessments, and validation planning activities.
• Coordinate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

Skills

CQV lifecycle experience

CQV validation documentation

Cross-functional coordination

Independent work style

10+ years experience

Technical writing

Education

Bachelor's degree in Engineering, Biotechnology, Life Sciences, or related field

Tools

Kneat

Job description

Verista in Apex, NC is seeking a Solution Preparation Principal CQV Engineer to lead commissioning, qualification and validation activities for solution preparation systems in biopharmaceutical manufacturing.

You will author and execute CQV documentation, ensure compliance with cGMP, support equipment startup and FAT/SAT, and collaborate with engineering, automation, QA, and manufacturing to deliver projects on time; onsite work in Apex, NC is required.