{"id":3872647,"url":"https://alion.io/job/syner-g-biopharma-group-project-engineer-5","title":"Project Engineer","company":{"id":2418043,"name":"Syner-G BioPharma Group","domain":"synergbiopharma.com","url":"https://alion.io/company/synergbiopharma","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":85,"open_postings":10,"ghost_share":0,"stale_share":0.4,"repost_share":0,"time_to_fill_p50_days":65,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Bioreactors","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-06T14:19:06Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-12T17:08:33Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"COMPANY DESCRIPTION: \nA career here is life-enhancing.\nAt 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 here. \nUnderpinning 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.\nSyner-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. \nAt 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. \nFor more information, visit www.Synergbiopharma.com\nPOSITION OVERVIEW:\nWe are seeking experienced Project Engineers to support commissioning and qualification activities within GMP-regulated biopharmaceutical manufacturing environments. This role will primarily focus on the development, execution, and documentation of Installation Qualification (IQ) protocols for bioreactors, media hold tanks, and associated process systems. The ideal candidate will possess hands-on CQV experience and a strong understanding of equipment qualification, engineering documentation, and GMP compliance requirements.\nWORK LOCATION:\nTravel to client sites may be required up to 100%, depending on project needs and client expectations.\nKEY RESPONSIBILITIES:\n(This list is not exhaustive and may be supplemented or adjusted as needed.)\nDevelop, review, and execute Installation Qualification (IQ) protocols for bioreactors, media hold tanks, and associated process equipment.\nVerify equipment installation against approved P&IDs, engineering specifications, vendor documentation, and design drawings.\nPerform field walkdowns, equipment inspections, and installation verification activities to ensure compliance with project and regulatory requirements.\nConfirm proper installation and identification of instrumentation, utilities, piping components, and process equipment.\nReview vendor turnover packages, material certifications, calibration records, equipment manuals, and supporting qualification documentation.\nIdentify, document, and support resolution of qualification discrepancies, punch list items, and deviations.\nCollaborate with Engineering, Manufacturing, Quality Assurance, Validation, and equipment vendors to support system turnover and qualification readiness.\nSupport commissioning and qualification activities in accordance with GMP, GDP, and site validation procedures.\nMaintain accurate and complete qualification documentation to support regulatory inspections and audits.\nCommunicate project status, execution risks, and qualification progress to stakeholders and project teams.\nEnsure all work is performed in compliance with site safety standards, quality requirements, and regulatory expectations.\nQUALIFICATIONS AND REQUIREMENTS\nTo 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.\nEducation\nBachelor's Degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.\nTechnical Experience\n3+ years of CQV, Validation, Engineering, or Technical Operations experience within biotechnology, pharmaceutical, or other GMP-regulated manufacturing environments.\nDemonstrated experience developing and executing IQ protocols for process equipment.\nExperience qualifying bioprocess equipment such as bioreactors, media preparation systems, media hold tanks, process vessels, and associated utility systems.\nExperience reviewing engineering documentation including P&IDs, equipment specifications, vendor packages, and turnover documentation.\nFamiliarity with commissioning, qualification, and validation lifecycle activities.\nWorking knowledge of GMP documentation practices, Good Documentation Practices (GDP), and regulatory compliance requirements.\nExperience utilizing electronic validation systems such as Kneat or similar validation platforms is preferred.\nKnowledge, Skills, and Abilities\nStrong understanding of CQV methodologies and equipment qualification principles.\nKnowledge of upstream bioprocess manufacturing systems and related equipment.\nAbility to interpret engineering drawings, P&IDs, and technical documentation.\nStrong technical writing, documentation, and organizational skills.\nAbility to manage multiple priorities in a fast-paced project environment.\nStrong analytical and problem-solving abilities with a high attention to detail.\nExcellent verbal and written communication skills.\nAbility to work independently and collaboratively within cross-functional teams.\nESSENTIAL FUNCTIONS:\nPhysical Demands: \nThe 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. \nWhile 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. \nWork Environment: \nThe 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. \nTOTAL REWARDS PROGRAM:\nWe 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.\nCurrently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. \nLEGAL STATEMENT:\n\nSyner-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. 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