6245 - Solution Prep 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 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: 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 t...