Senior Validation Engineer (QAV) at Syner-G BioPharma Group

Greenville, North Carolina, United StatesFull-timeTechnical Operations (Southeast Region)Posted 17 days ago

About the Role

<div class="content-intro">COMPANY DESCRIPTION:  A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video <a href="https://www.youtube.com/watch?v=2rUMvtncuw8">here</a>.  Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.  At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.  For more information, visit <a id="menur1aj1" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="https://www.synergbiopharma.com/" target="_blank">www.Synergbiopharma.com</a></div>  <div> POSITION OVERVIEW: We are seeking a Senior Validation Engineer (QAV) with 4-15 years of experience to support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures. The Senior Validation Engineer (QAV) will support MES and eBR implementation and qualification activities, working closely with cross-functional teams including Manufacturing, Validation, Automation, IT/OT, and Quality. The successful candidate will contribute to validation strategy, execution, documentation review, and system release activities while ensuring alignment with GMP and computerized systems validation requirements. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or adjusted as needed.) <ul> <li>Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and validation reports for equipment, utilities, facilities, computerized systems, and other GMP-regulated assets.</li> <li>Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities.</li> <li>Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies.</li> <li>Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements.</li> <li>Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.</li> <li>Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities.</li> <li>Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications.</li> <li>Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.</li> <li>Prepare validation summary reports and support qualification and requalification activities.</li> <li>Participate in commissioning and qualification activities, including system walkdowns and verification exercises.</li> <li>Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable.</li> <li>Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.</li> <li>Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness.</li> <li>Maintain validation documentation in accordance with quality system requirements and document control procedures.</li> </ul> QUALIFICATIONS AND REQUIREMENTS: Education <ul> <li>Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.</li> </ul> Technical Experience <ul> <li>Provide QA/validation oversight for MES and eBR implementation and qualification.</li> <li>Review and approve requirements, risk assessments, test protocols, deviations, traceability, and validation reports.</li> <li>Review eBR workflows for alignment with approved manufacturing processes and batch records.</li> <li>Ensure compliance with 21 CFR Part 11, GMP, data integrity, and CSV requirements.</li> <li>Support deviation investigations, change controls, system release, and go-live activities.</li> <li>Work closely with Manufacturing, Validation, Automation, IT/OT, and Quality teams.</li> </ul> Knowledge, Skills, and Abilities <ul> <li>Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements.</li> <li>Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.</li> <li>Strong technical writing and documentation skills with attention to detail.</li> <li>Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts.</li> <li>Strong organizational, analytical, and problem-solving abilities.</li> <li>Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.</li> <li>Ability to manage multiple assignments and priorities in a fast-paced project environment.</li> <li>Working knowledge of validation lifecycle deliverables and quality system processes.</li> <li>Ability to work independently while contributing effectively within cross-functional teams.</li> <li>Demonstrated MES/eBR validation experience.</li> <li>Experience with PAS-X, PharmaSuite, Syncade, Opcenter, or similar MES platforms preferred.</li> <li>Strong understanding of GMP manufacturing, 21 CFR Part 11, data integrity, and validation lifecycle documentation.</li> <li>Strong technical writing, documentation review, and cross-functional communication skills.</li> </ul> </div>   ESSENTIAL FUNCTIONS:  Physical Demands:  The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.  Work Environment:  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.  TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.  LEGAL STATEMENT:   Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

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