Principal Process Engineer

Upstream Principal Engineer / Lead Validation EngineerHolly Springs, NCVerista'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 an Upstream Principal Engineer is responsible for overseeing the commissioning and qualification of Upstream systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.Upstream Principal Engineer Responsibilities:Upstream System LeadershipServe as the commissioning and qualification lead for Upstream systems (responsibilities described below).Specific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems.C&Q Lead ResponsibilitiesCommissioning and Qualification DocumentationGain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).Engage with design engineers and SMEs to clarify system intent and operational requirements.Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation.Create Commissioning Test Plans that translate design intent into testable steps.Coordinate with the Automation Team to incorporate all automation functional testing.Collaborate with SMEs to ensure system requirements are accurately reflected in test plans.Develop Installation, Operational, and Qualification (IOQ) protocols.Prepare and submit summary reports documenting commissioning and qualification activities.System Ownership and ExecutionTake custody of the system post-construction and maintain ownership through C&Q completion.Perform Lockout/Tagout (LOTO) for system safety.Conduct pre-startup safety checks and risk assessments.Prepare daily pre-task plans and verify team readiness for safe execution.Attend daily commissioning meetings to coordinate activities.Execute commissioning and IOQ protocols.Resolve issues arising during execution.Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.Requirements:Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline10+ years of role specific experienceExperience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environmentsHands-on experience with downstream bioprocess equipment and purification systemsStrong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)Ability to work independently while collaborating with cross-functional teamsStrong documentation, organizational, and communication skillsExperience with digital validation systems such as KneatExperience supporting FAT/SAT, commissioning, and equipment startupFamiliarity with risk-based validation approachesExperience in biologics manufacturing or monoclonal antibody production environmentsOnsite job requirement in Holly Springs, 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$107,800 - $168,011 USDBenefitsHigh 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. If you are a California Job Applicant, see the privacy notice for further details.For more information about our company, please visit us at Verista.com