Senior Solution Prep Engineer | CQV for Biopharma

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

Benefits offered by this job

Medical, Dental & Vision

401(k) with company matching

Paid Time Off

Job summary

Verista is seeking a Solution Prep Principal Engineer in Apex, NC to lead CQV activities for solution, buffer, and media preparation systems in biopharma manufacturing. You will author and execute IQ/OQ/PQ protocols, ensure cGMP compliance, and collaborate with engineering, automation, quality, and manufacturing teams to drive project readiness.

The role requires 10+ years in CQV within regulated environments, hands-on experience with Kneat or similar digital validation platforms, and onsite

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related field.
• 10+ years of role-specific experience.
• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments.
• Hands-on experience with solution preparation, buffer prep, or media prep systems.
• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports).
• Ability to work independently while coordinating with cross-functional teams.

Responsibilities

• Support CQV activities for solution preparation systems used in biopharmaceutical manufacturing.
• Author, review, and execute CQV documentation including IQ/OQ/PQ protocols, IQ, OQ, PQ, and validation 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

Technical documentation

Cross-functional collaboration

Independent worker

Communication skills

Education

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

Tools

Kneat

Job description

Verista is seeking a Solution Prep Principal Engineer in Apex, NC to lead CQV activities for solution, buffer, and media preparation systems in biopharma manufacturing. You will author and execute IQ/OQ/PQ protocols, ensure cGMP compliance, and collaborate with engineering, automation, quality, and manufacturing teams to drive project readiness.

The role requires 10+ years in CQV within regulated environments, hands-on experience with Kneat or similar digital validation platforms, and onsite