6245 - Solution Prep Principal CQV Engineer / Lead Validation Engineer

Job Description DescriptionApply now, read the job details by scrolling down Double check you have the necessary skills before sending an application.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 colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseWe 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 expectationsThe 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 & ValidationSupport commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.Author, review, and execute CQV lifecycle documentation including:Commissioning test protocolsInstallation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Validation summary reportsEnsure validation documentation complies with cGMP regulations and internal quality proceduresParticipate in system impact assessments, risk assessments, and validation planning activitiesSolution Preparation Process SupportProvide technical support for solution preparation unit operations, including systems such as:Buffer preparation systemsMedia preparation systemsSolution preparation tanks and mixing systemsSingle-use mixing systemsTransfer and hold systemsSupport equipment startup and operational readiness for solution preparation processes.Assist with troubleshooting and process verification during commissioning and qualification activities.Vendor & Equipment StartupSupport 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 CoordinationCollaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.Assist with deviation investigations, change control processes, and documentation updatesEnsure CQV activities align with project schedules and operational readiness milestonesDigital Validation SystemsUtilize 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 fieldExperience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environmentsHands-on experience with solution preparation, buffer prep, or media prep systemsStrong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)Ability to work independently while coordinating with cross-functional teamsStrong technical documentation and communication skillsExperience using digital validation platforms such as KneatExperience supporting FAT/SAT, commissioning, and equipment startupFamiliarity with single-use systems and biologics manufacturing processesExperience working within biologics or cell culture manufacturing facilitiesOnsite job requirement in Apex, NCFor 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.*Verista is an equal opportunity employer.National (US) Range$87,780—$136,225 USDBenefitsWhy Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementVerista collects and processes personal data in accordance with applicable data protection laws. xhyhwjd If you are a California Job Applicant, see the privacy notice for further details. 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