6245 - Solution Prep Principal Engineer / Lead Validation Engineer

We are seeking a Solution Prep Principal 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 Engineer Responsibilities:

Commissioning, Qualification & Validation

• 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