Sr. Validation Engineer at Syner-G BioPharma Group

Raleigh, North Carolina, United StatesFull-timeTechnical Operations (East Coast)Posted about 2 months 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> POSITION OVERVIEW We are seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members. KEY RESPONSIBILITIES (This list is not exhaustive and may be supplemented or adjusted as needed.) <ul> <li>Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.</li> <li>Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.</li> <li>Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.</li> <li>Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.</li> <li>Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.</li> <li>Lead P&ID walkdowns to verify installation, configuration, and system readiness.</li> <li>Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.</li> <li>Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.</li> <li>Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.</li> <li>Provide technical mentorship and guidance to junior validation staff.</li> <li>Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs.</li> </ul> QUALIFICATIONS AND REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education <ul> <li>Bachelor’s degree in a life science, engineering, or related technical field.</li> </ul> Technical Experience <ul> <li>7–11 years of experience in the biotech, pharmaceutical, or medical device industry.</li> <li>Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.</li> <li>Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.</li> <li>Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.</li> <li>Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.</li> <li>Experience supporting audits, regulatory inspections, and remediation activities.</li> </ul> Knowledge, Skills, and Abilities <ul> <li>Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences.</li> <li>Highly organized with strong documentation and analytical skills.</li> <li>Ability to lead validation workstreams, manage multiple priorities, and work independently.</li> <li>Strong problem‑solving skills and experience supporting investigations and root‑cause analysis.</li> <li>Ability to mentor junior engineers and contribute to team development.</li> </ul>   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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