6242 - Upstream Principal CQV Engineer / Lead Validation Engineer

Holly Springs, NC 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 in upstream bioprocessing systems to support commissioning, qualification, and validation activities for biopharmaceutical manufacturing operations. This role will focus on upstream unit operations and process equipment , ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations . The ideal candidate will bring strong experience across the CQV lifecycle , including authoring validation documentation, coordinating commissioning activities, supporting vendor testing, and ensuring systems achieve operational readiness. Experience with digital validation platforms such as Kneat is highly desirable. This position requires someone who can work independently while collaborating cross‑functionally with engineering, automation, vendors, and quality teams to ensure successful project execution. Responsibilities Support commissioning, qualification, and validation (CQV) activities for upstream bioprocess equipment and systems. Author, review, and execute CQV lifecycle documentation including commissioning test protocols, Operational Qualification (OQ), Performance Qualification (PQ), and validation summary reports. Ensure validation documentation aligns with cGMP requirements and regulatory expectations . Participate in system impact assessments, risk assessments, and validation planning activities. Provide technical support for upstream bioprocess unit operations such as media and buffer preparation systems, cell culture support equipment, filtration and upstream utilities. Support equipment startup and operational readiness; assist in troubleshooting and performance verification. Collaborate with engineering and operations teams during commissioning and qualification. Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment. Coordinate with equipment vendors and integrators to ensure proper system installation and functionality. Work closely with engineering, automation, quality assurance, and manufacturing teams; align project deliverables with timelines and milestones. Assist with deviation resolution, change control, and documentation updates. Utilize electronic validation platforms (e.g., Kneat) to develop and execute validation documentation; maintain documentation integrity and traceability. Qualifications Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical field. Experience supporting CQV activities within GMP‑regulated pharmaceutical or biotechnology environments. Hands‑on experience with upstream bioprocess equipment and systems. Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ, protocols, reports). Ability to work cross‑functionally with engineering, automation, vendors, and quality teams. Strong communication, documentation, and organizational skills. Experience with digital validation platforms such as Kneat. Experience supporting FAT/SAT, commissioning, and equipment startup. Familiarity with risk‑based validation approaches. Prior experience in biologics or cell culture manufacturing environments. On‑site job requirement in Holly Springs, NC. 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. Supplemental Life, Hospital, Critical Illness and Legal Insurance. Health Savings Account. Paid Time Off (Rollover Option) and Holidays. As Needed Sick Time. Tuition Reimbursement. Team Social Activities. Employee Recognition. Employee Referral Program. Paid Parental Leave and Bereavement. Salary National (US) Range

$87,780 - $136,225 USD

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