6243 - Downstream Principal Engineer / Lead Validation Engineer

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