{"id":1644156,"url":"https://alion.io/job/precigen-process-engineer-drug-substance-manufacturing","title":"Process Engineer - Drug Substance Manufacturing","company":{"id":3188444,"name":"Precigen","domain":"precigen.com","url":"https://alion.io/company/precigen","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Germantown, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":90000,"max":110000,"currency":"USD","period":"year","gross":null,"usd_annual":110000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-14T19:14:00Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-10-13T16:34:20Z","board_verified":true,"closed_at":null,"days_open":30,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":30},"description":"Precigen is a dedicated commercial and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.\nPrecigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.\nWe are seeking a Process Engineer - Drug Substance Manufacturing to support the Precigen, Inc. drug substance manufacturing. This position will require a professional who is technically savvy, thrives in a dynamic team environment, poses exceptional problem-solving skills, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will be supporting all technical aspects of Gene Therapy cGMP manufacturing clinical stages to commercialization of Adenovector products, including process transfer, process validation, continuous process verification, manufacturing facility startup, and regulatory filings.\nDUTIES AND RESPONSIBILITIES:\nResponsible for end-to-end technical support of gene therapy product manufacturing (Drug Substance).\nProvide process engineering support for facility design, construction, commissioning, and startup projects.\nWorks cross functionally with Process Development, CMO, Quality Assurance, Quality Control, Supply Chain, and Validation departments to effectively transfer, implement and maintain processes at multiple facilities.\nWorks closely with internal manufacturing teams to provide on-the-floor technical oversight through each product campaign startup as well as in response to any process/equipment troubleshooting requirements related to gene therapy manufacturing.\nCollect and trend process data, perform process capability assessments, and identify areas for continuous improvement related to gene therapy manufacturing.\nAuthors and/or reviews technical reports, process tech transfer summary reports, risk assessments, master batch records, equipment user requirement specifications, and protocols in support of tech transfer, cGMP activities and regulatory filings.\nProvide technical support for investigations and lend expertise in problem solving activities on existing production activities, determining root cause and corrective actions.\nOffer subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions, and Validation protocols.\nOther duties as assigned.\nEDUCATION AND EXPERIENCE:\nB.Sc or M.Sc in Chemical Engineering, Bioengineering, or another relevant engineering degree. Level will be determined based on education and experience.\n3-4 years of experience in a biopharmaceutical manufacturing setting where the individual has implemented process changes/optimization, technology transfer, and manufacturing support.\nExperience in process development and/or process engineering of Drug substance\nExperience summarizing and presenting data, statistical analysis, and authoring technical reports.\nStrong computer skills with Microsoft Office, data trending/management software (Excel and Jmp) and the ability to quickly learn new applications.\nDESIRED KEY COMPETENCIES:\nExperience with manufacturing facility design and startup\nStrong technical and scientific knowledge of drug substance manufacturing operations.\nExperience with manufacture of viral vectors and/or viral vaccines is a plus\nCritical thinking and strong problem-solving skills with quantitative and analytical mind-set.\nSelf-organizer, meticulous hands-on habits, keen attention to detail.\nPerform other responsibilities to support the needs of the department, as assigned.\nExcellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.\nKnowledge and experience in Operational Excellence (OE) methodologies is a plus.\nMaintains a high degree of ethical standard and trustworthiness.\nDemonstrates the ability to mentor and coach team members in all areas of expertise.\nOccasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.\nEOEMFDV","description_format":"text","description_chars":4393,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO 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