6243 - Downstream Principal CQV Engineer / Lead Validation Engineer

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.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

We are seeking a CQV Engineer with hands-on experience in downstream bioprocessing systems to support commissioning, qualification, and validation activities within biopharmaceutical manufacturing environments. This role will focus on downstream unit operations and purification equipment, ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working with 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.

Downstream Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for downstream bioprocess equipment and systems.

• 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, regulatory standards, and internal quality procedures.

• Participate in system impact assessments, risk assessments, and validation planning activities.

Downstream Bioprocess Support

• Provide technical support for downstream purification unit operations, including systems such as:

  • Chromatography systems

  • Tangential Flow Filtration (TFF) / Ultrafiltration systems

  • Depth filtration systems

  • Viral filtration systems

  • Buffer preparation and hold systems

• Support equipment startup and operational readiness for downstream process systems.

• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Startup Activities

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new downstream process equipment.

• Coordinate with equipment vendors and system integrators to ensure proper installation and functionality.

• Participate in equipment startup, commissioning, and performance verification activities.

Cross-Functional Coordination

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Support deviation investigations, change controls, and documentation updates as required.

• Ensure CQV activities are completed in accordance with project schedules and milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to author, manage, and execute validation documentation.

• Maintain documentation integrity and traceability within digital validation systems.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline

• Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with downstream bioprocess equipment and purification systems

• Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)

• Ability to work independently while collaborating with cross-functional teams

• Strong documentation, organizational, and communication skills

• Experience with digital validation systems such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with risk-based validation approaches

• Experience in biologics manufacturing or monoclonal antibody production environments

• Onsite job requirement in Holly Springs, NC

Benefits

Why Choose Verista?

• 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

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For more information about our company, please visit us at Verista.com