{"id":1642101,"url":"https://alion.io/job/arrowhead-pharmaceuticals-ireland-limited-engineer-i-process-validation","title":"Engineer I, Process Validation","company":{"id":2094071,"name":"Arrowhead Pharmaceuticals Ireland Limited","domain":"arrowheadpharma.com","url":"https://alion.io/company/arrowheadpharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":91,"open_postings":13,"ghost_share":0,"stale_share":0.154,"repost_share":0,"time_to_fill_p50_days":73,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Verona, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":90000,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"closed","first_seen_at":"2026-09-18T14:29:46Z","employer_posted_date":"2026-09-18","last_verified_at":"2026-10-27T18:09:02Z","board_verified":false,"closed_at":"2026-10-27T18:09:02Z","days_open":39,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":39},"description":"Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.\nArrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.\nArrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. \nThe Position\nThe Process Validation Engineer will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation.\nResponsibilities\nDraft and review process validation and cleaning validation protocols and reports, ensuring compliance with GMP regulations.\nOversee and manage the execution of manufacturing validation activities, ensuring timelines and quality standards are met.\nCollaborate with cross-functional teams to ensure validation strategies align with production requirements and regulatory guidelines.\nProvide technical support to manufacturing during validation and qualification activities.\nIdentify and assess risks, proposing corrective actions and improvements to enhance validation processes.\nEnsure compliance with all applicable regulatory requirements, including FDA, EMA, and ICH guidelines.\nReview and approve validation data and documentation to ensure accuracy and regulatory compliance.\nParticipate in audits and inspections, providing validation documentation and responding to inquiries from regulatory agencies.\nProvide training and mentorship to employees on validation processes and GMP standards.\nRequirements\nBS/BA in an applicable scientific field such as chemistry, biology, or biochemistry\nStrong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.\nExcellent technical writing skills with high attention to detail\nProficiency in Microsoft Word and Excel\nAbility to work across teams\nExperience in drafting and reviewing validation protocols and reports.\nStrong understanding of GMP regulations, validation principles, and industry best practices.\nMinimum 5 years of experience in GMP validation or a related field, with at least 3 years of GMP manufacturing experience preferred.\nKnowledge of process and cleaning validation activities, including test methods, execution, and data analysis.\nExcellent problem-solving skills and attention to detail.\nStrong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.\nExperience with regulatory submissions and/or inspections.\nExperience in a pharmaceutical or biopharmaceutical manufacturing environment.\nExperience working in a GMP setting\nExperience with controlled documentation\nPreferred\n8 years of experience in GMP validation or a related field\nSix Sigma or Lean certifications are a plus.\nWisconsin pay range\n$90,000—$120,000 USD\nArrowhead provides competitive salaries and an excellent benefit package. \nCandidates must have current, valid authorization to work in the country where this role is located.\nCalifornia Applicant Privacy 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