{"id":4250403,"url":"https://alion.io/job/biomarin-pharmaceutical-inc-senior-engineer-global-process-validation","title":"Senior Engineer, Global Process Validation","company":{"id":2702,"name":"BioMarin Pharmaceutical Inc.","domain":"biomarin.com","url":"https://alion.io/company/biomarin-pharmaceutical-inc","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Jobvite","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cork, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-13T14:06:47Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-13T20:39:29Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Description\nWho We Are \nBioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.\nGuided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.\nOur success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. \nAbout Technical Operations \nBioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.\nSenior Engineer, Global Process Validation\nHybrid - Shanbally, Ringaskiddy, Cork\nClosing Date: 16th November 2026\nSummary Description\nThe Senior Engineer, Global Process Validation reports to the Senior Manager, Global Process Validation and is responsible for supporting lifecycle process validation and technical assessment activities within a global cGMP environment. This position leads and coordinates projects associated with the implementation of new manufacturing processes, process improvements, technology transfers, and commercial lifecycle management activities across drug substance manufacturing operations.\nThe role provides technical leadership for process validation and associated technical assessments supporting enzyme replacement therapies and other advanced medicines produced by various process modalities including biologics, conventional small molecules, peptides, and oligonucleotides. Activities may include but are not limited to manufacturing process validation, filtration studies, mixing and hold time evaluations, process characterization studies, shipping qualification, technology transfer, microbial/contamination control evaluations, and risk-based impact assessments. The position supports validation lifecycle activities consistent with FDA, EMA, ICH, and international regulatory expectations.\nThis individual operates in a highly cross-functional environment and is expected to independently manage technical projects, author and review validation documentation, perform scientific evaluations, communicate recommendations, and support regulatory inspections and submissions.\nResponsibilities\nLead process validation activities for drug substance manufacturing processes from late-stage development through commercial lifecycle management.\nDevelop and execute risk basedvalidation strategies consistent with lifecycle process validation principles, including process design, process qualification, and continued process verification.\nAuthor and review validation master plans, protocols, reports, risk assessments, technical assessments, and supporting regulatory documentation.\nSupport implementation of new processes, process changes, manufacturing site transfers, and capacity expansion projects.\nPerform technical evaluations supporting manufacturing process changes, deviations, investigations, CAPAs, and change controls.\nLead process impact assessments and risk-based evaluations utilizing tools such as FMEA and other quality risk management methodologies.\nCollaborate with Manufacturing, Manufacturing Sciences, Technical Development, Quality, Regulatory Affairs, Engineering, Supply Chain, and external partners to ensure successful project execution.\nSupport generation and review of Common Technical Document (CTD) sections and responses to regulatory authority questions.\nProvide technical assessment and oversight for: Extractables and leachables studies, Container closure system evaluations, Material compatibility assessments, Single-use technology evaluations, Shipping and distribution assessments, Facilities/Utilities/Equipment (FUE) Qualification, Cleaning Validation, microbial/contamination control assessments, Process characterization studies, Comparability evaluations.\nReview toxicological risk assessments and scientific justifications supporting material and manufacturing changes.\nEvaluate supplier and contract manufacturing data packages supporting process validation and technical assessments.\nCoordinate activities with contract manufacturing organizations, contract laboratories, and internal manufacturing sites.\nParticipate in regulatory inspections, partner audits, and internal audits as a subject matter expert.\nIdentify opportunities to improve validation systems, procedures, and business processes.\nMentor junior engineers and technical staff in validation principles, risk-based decision making, and technical assessment approaches.\nRemain current with evolving industry guidance, emerging technologies, and regulatory expectations.\nScope\nThe Senior Engineer plays a significant role in the approval and implementation of manufacturing processes and technical systems supporting commercial product supply. Decisions and recommendations made by this position may directly impact product quality, regulatory compliance, manufacturing readiness, and supply continuity.\nThe position routinely influences project timelines, validation strategies, technical decisions, and regulatory risk assessments that affect global manufacturing operations and external partners.\nEducation\nBachelor's degree in Chemical/Biochemical Engineering, Engineering, Biological Sciences, Pharmaceutical Sciences, Chemistry, or related technical discipline required.\nMaster's degree or advanced scientific degree is advantageous.\nFormal training in project management or quality risk management is advantageous.\nExperience\n8+ years of experience in a cGMP-regulated biotechnology or pharmaceutical manufacturing environment preferred.\nDemonstrated expertise in manufacturing processes and control strategy with associated experience supporting process validation, technical development, manufacturing, manufacturing sciences, engineering, or related technical functions.\nExperience independently developing risk-based validation approaches as well as authoring and reviewing validation protocols, reports, and supporting technical assessments.\nExperience with biologics, peptides, oligonucleotides, small moleculesor advanced therapy products preferred.\nWorking knowledge of FDA, EMA, ICH, Annex 1, and global regulatory expectations governing process validation.\nStrong communication particularly in technical writing, presentation skills, and ability to influence technical decisions.\nDemonstrated ability to lead cross-functional projects and to track and on time delivery of project milestones.\nExperience interacting with regulatory authorities, auditors, or inspection teams is preferred.\nComfort exploring the use of new tools and technologies such as AI (e.g. Cowork)\nSkills & Competencies\nProcess Validation Lifecycle Management\nQuality Risk Management\nTechnical Assessment Development\nMicrobial and contamination control\nProcess Characterization\nTechnology Transfer\nChange Control\nData Analysis and Statistical Evaluation\nProject Management\nRegulatory Compliance\nTechnical Writing and Communication\nCross-functional Leadership\nSupervisor Responsibility\nNo direct reports required.May provide technical leadership, mentoring, and project oversight for junior engineers, contractors, and cross-functional teams.\nNote: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. \nEqual Opportunity Employer/Veterans/Disabled \nAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.\nIreland Safety Responsibility\nSupport the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.","description_format":"text","description_chars":9211,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-13T14:06:47Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":30,"reasons":["conf:0","win:early"],"computed_at":"2026-11-13T21:01:39Z"},"pay":null,"html_url":"https://alion.io/job/biomarin-pharmaceutical-inc-senior-engineer-global-process-validation","json_url":"https://alion.io/job/biomarin-pharmaceutical-inc-senior-engineer-global-process-validation.json","meta":{"generated_at":"2026-11-13T21:01:39Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":41897,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2702},"rest":"https://alion.io/mcp/rest/get_company?id=2702"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbiomarin-pharmaceutical-inc-senior-engineer-global-process-validation"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbiomarin-pharmaceutical-inc-senior-engineer-global-process-validation"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbiomarin-pharmaceutical-inc-senior-engineer-global-process-validation"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/biomarin-pharmaceutical-inc-senior-engineer-global-process-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbiomarin-pharmaceutical-inc-senior-engineer-global-process-validation"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4250403}},{"tool":"search_jobs","arguments":{"company":"biomarin.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4250403},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}