6245 - Solution Prep Principal Engineer / Lead Validation Engineer

Veristainc; North Carolina; On-site; USD 107,800 - 168,011; Full time

Benefits offered by this job

401(k) Retirement Plan with Employer Matching

Medical, Dental & Vision insurance

Paid Time Off and Holidays

Job summary

Veristainc is seeking a CQV Engineer to support solution preparation systems in biopharmaceutical manufacturing. The ideal candidate will have over 10 years of experience and strong skills in CQV lifecycle documentation, as well as a bachelor's degree in a related field.

This role also requires collaboration across engineering and quality teams and experience with digital validation platforms like Kneat. Competitive salary and benefits are included.

Qualifications

• 10+ years of role specific experience.
• Hands-on experience with solution preparation, buffer prep, or media prep systems.
• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports).
• Experience working within biologics or cell culture manufacturing facilities.

Responsibilities

• Support commissioning, qualification, and validation (CQV) activities for solution preparation systems.
• Author and review CQV lifecycle documentation including commissioning and validation protocols.
• Collaborate with engineering and quality assurance teams to align project deliverables.
• Utilize electronic platforms (e.g., Kneat) for managing validation documentation.

Skills

CQV lifecycle documentation

Collaboration with cross-functional teams

Technical documentation skills

Experience with digital validation platforms

Experience supporting equipment startup

Education

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

Tools

Kneat

Buffer preparation systems

Media preparation systems

Job description

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision‑making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world‑class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

We are seeking a CQV Engineer with hands‑on experience supporting solution preparation systems within biopharmaceutical manufacturing environments. This role will focus on solution preparation, buffer preparation, and media preparation unit operations, supporting commissioning, qualification, and validation activities to ensure systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting equipment startup and commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.

This position requires an individual who can work independently while collaborating cross‑functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Solution Preparation Principal CQV Engineer Responsibilities:

• Support commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.
• Author, review, and execute CQV lifecycle documentation including:
  • Commissioning test protocols
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation summary reports
• Ensure validation documentation complies with cGMP regulations and internal quality procedures.
• Participate in system impact assessments, risk assessments, and validation planning activities.

Solution Preparation Process Support

• Provide technical support for solution preparation unit operations, including systems such as:
  • Buffer preparation systems
  • Media preparation systems
  • Solution preparation tanks and mixing systems
  • Single‑use mixing systems
  • Transfer and hold systems
• Support equipment startup and operational readiness for solution preparation processes.
• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Equipment Startup

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.
• Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.
• Participate in equipment startup, commissioning, and operational testing activities.

Cross‑Functional Coordination

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.
• Assist with deviation investigations, change control processes, and documentation updates.
• Ensure CQV activities align with project schedules and operational readiness milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.
• Maintain data integrity, traceability, and compliance within digital validation systems.

Requirements:

• 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 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
• Strong technical documentation and communication skills
• Experience using digital validation platforms such as Kneat
• Experience supporting FAT/SAT, commissioning, and equipment startup
• Familiarity with single‑use systems and biologics manufacturing processes
• Experience working within biologics or cell culture manufacturing facilities
• Onsite job requirement in Apex, NC

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
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws.

Verista is an equal opportunity employer.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job‑related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

National (US) Range: $107,800 — $168,011 USD