Senior Validation Engineer (QAV) Greenville, North Carolina, United States

KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or adjusted as needed.) 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. Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities. Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies. Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements. Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements. Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities. Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications. Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements. Prepare validation summary reports and support qualification and requalification activities. Participate in commissioning and qualification activities, including system walkdowns and verification exercises. Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable. Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems. Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness. Maintain validation documentation in accordance with quality system requirements and document control procedures.

QUALIFICATIONS AND REQUIREMENTS: Education Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field. Technical Experience Provide QA/validation oversight for MES and eBR implementation and qualification. Review and approve requirements, risk assessments, test protocols, deviations, traceability, and validation reports. Review eBR workflows for alignment with approved manufacturing processes and batch records. Ensure compliance with 21 CFR Part 11, GMP, data integrity, and CSV requirements. Support deviation investigations, change controls, system release, and go-live activities. Work closely with Manufacturing, Validation, Automation, IT/OT, and Quality teams. Knowledge, Skills, and Abilities Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements. Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment. Strong technical writing and documentation skills with attention to detail. Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts. Strong organizational, analytical, and problem‑solving abilities. Effective verbal and written communication skills with the ability to collaborate across multiple functional areas. Ability to manage multiple assignments and priorities in a fast‑paced project environment. Working knowledge of validation lifecycle deliverables and quality system processes. Ability to work independently while contributing effectively within cross‑functional teams. Demonstrated MES/eBR validation experience. Experience with PAS‑X, PharmaSuite, Syncade, Opcenter, or similar MES platforms preferred. Strong understanding of GMP manufacturing, 21 CFR Part 11, data integrity, and validation lifecycle documentation. Strong technical writing, documentation review, and cross‑functional communication skills.

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. 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. 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 Affimative 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. U.S. Standard Demographic Questions We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process. How would you describe your gender identity? (mark all that apply) Select... How would you describe your racial/ethnic background? (mark all that apply) Select... How would you describe your sexual orientation? (mark all that apply) Select... Do you identify as transgender? Select... Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning? Select... Are you a veteran or active member of the United States Armed Forces? Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Syner-G’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the United States military, ground, naval or ... An "Armed forces service medal veteran" ...