6242 - Upstream Principal Engineer / Lead Validation Engineer

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. We 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.

Responsibilities

Serve as the commissioning and qualification lead for Upstream systems; Gain 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; Take 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 discipline; 10+ years of role specific experience; 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; Specific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems

Benefits

High growth potential and fast-paced organization with a people-focused culture; Competitive pay plus performance-based incentive programs; Company-paid Life, Short-Term, and Long-Term Disability Insurance; Medical, Dental & Vision insurances; FSA, DCARE, Commuter Benefits; Supplemental Life, Hospital, Critical Illness and Legal Insurance; Health Savings Account; 401(k) Retirement Plan (Employer Matching benefit); Paid Time Off (Rollover Option) and Holidays; As Needed Sick Time; Tuition Reimbursement; Team Social Activities (We have fun!); Employee Recognition; Employee Referral Program; Paid Parental Leave and Bereavement