{"id":3529934,"url":"https://alion.io/job/psc-biotechr-senior-specialist-process-engineer","title":"Senior Specialist -Process Engineer","company":{"id":4424516,"name":"PSC Biotech®","domain":"biotech.com","url":"https://alion.io/company/psc-biotech","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Zoho Recruit","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Dublin, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":72000,"max_usd":124000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":63},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"FMEA","optional":false},{"name":"Statistical Process Control","optional":false},{"name":"Cell Culture","optional":true},{"name":"JMP","optional":true}],"status":"live","first_seen_at":"2026-10-30T15:45:39Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-01T10:42:37Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"About PSC Biotech\nWho are we?\nPSC Biotech is a leading Biotech Consultancy firm founded\nin 1996, headquartered in Pomona, California, USA, with Global operations in\nIreland, India, Singapore, Australia and the US, serving 350 clients in more\nthan 23 countries worldwide. We provide cloud-based software solutions for\nQuality Management and Regulatory Inspections, pharmaceuticals contract\nmanufacturing professionals, and metrology services to our clients.\n‘Take your Career to a new Level’\nPSC Biotech disrupts the conventional consultancy model\nby aligning our EVP as one of the unique selling point which includes the\nopportunity to work with the most talented cohort of like-minded professionals\noperating in the Pharma/ Biotech Industry. We offer a permanent contract of\nemployment giving exposure of working in Top Pharmaceutical client sites in a\ndiverse-cultural work setting.\nEmployee Value Proposition\nEmployees are the “heartbeat” of PSC Biotech, we provide\nunparalleled empowering career development though Learning & Development\nin-house training mentorship through constant guidance to facilitate career\nprogression. We believe in creating high performing teams that can exceed our\nclient’s expectations with regards to quality of all scalable and business unit\nOverview\nThe Senior Specialist - Engineering’s role will be\nessential in ensuring efficient and effective compliant design, construction,\nqualification, approval and operation of the new state-of-the-art facility\nduring the initial project phase. The successful candidate will take a lead on\nutilising the latest innovations in technology and automation to create a\nworkplace of the future.\nRequirements\nRole:\nReporting through the site manufacturing and technologyhead and based at the site, the Senior Specialist, Process Engineering\nresponsibilities include, but are not limited to the following:\n\nSupport the design, construction and qualification ofupstream & downstream equipment through to technology transfer and\ncommercialization.\n\nSupport establishment of the commercial process androutine manufacturing by:\n\nSupporting experimental design, execution, data analysisand interpretation.\n\nInterpreting trends observed in commercial processmonitoring (e.g., proactive process analysis (PPA), continued process\nverification (CPV), statistical process control (SPC) multivariate analyses\n(MVDA)), and for further technical investigations and process changes that seek\nto drive improvements to yield and/or robustness.\n\nSupporting deviation management.\nSupporting change control prioritization andimplementation.\n\nAuthoring and reviewing of batch documentation, technicalreports and global regulatory submissions.\n\nSupporting multidisciplinary teams (manufacturing scienceand technology, quality, analytics, regulatory) for process improvement and\ntroubleshooting with end-to-end product focus.\n\nApplying Lean Six Sigma tools by:\nSecuring continuity of an appropriate LSS/CEM level ofknowledge.\n\nFacilitating problem solving & risk assessment (FMEA)projects/meetings.\n\nMaking problems visible and strive for continuousimprovement.\n\nServing as a key member during internal audits andexternal inspections/audits\n\nLead and support various manufacturing science andtechnology organizational initiatives as needed (examples include safety,\nfinancial forecasting, work standardization, etc).\n\nMaintain continuous focus on quality and safetycompliance and unflinching focus on the customer.\n\nAdditional Info:\nPotential requirement to go on shift for 3 weeks only (4days on - 2 days, 2 nights, 4 days off)\n\nHybrid requirement - The successful candidate must work 3days onsite each week, and one of those onsite days must be either Monday or\nFriday.\n\nThe position is scheduled to start on 4 January 2027, andalternative start dates are not being considered.\n\nNew requirement for a new tech transfer project - Thisrole supports a new technology transfer (Tech Transfer) project. Candidates\nwith NPI (New Product Introduction) and/or Biopharma industry experience will\nbe preferred during the shortlisting process.\n\nThe Candidate should have:\nThis role requires an experienced individual with aminimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experience\nin academia, pharmaceutical or biotechnology company - along with a working\nknowledge of current regulatory requirements and current Good Manufacturing\nPractices.\n\nA self-starter and results-focussed, the successfulcandidate will have strong contemporary knowledge, and the ability to work\nindependently and on multidisciplinary teams. The successful candidate will\nalso have demonstrated the ability to deliver what is needed on-time, holding\nself and team accountable for commitments, decisions, actions and behaviours.\n\nS/he will also have excellent oral and writtencommunication skills, with the ability to effectively articulate understanding\nof process science, in order to drive decision making, impact assessments,\ndesign of studies, etc., in a multi-disciplinary team environment.\n\nWith a Bachelor’s degree (or higher) in BiologicalSciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without\nindustry experience), the successful candidate will also ideally have a proven\ntrack record in delivering excellence. The candidate will also show ambition\nand drive to develop and advance their career\n\nPreferred Experience and Skills:\nExperience with upstream cell culture and/or downstreampurification of biological molecules.Experience with technology transfer, regulatory filing, and commercial\ndrug substance manufacturing of biologics is a plus.\n\nTechnical operations experience in the drug substancemanufacture of biological molecules at commercial-scale.\n\nPrior experience in drug substance process development,process characterisation studies, process performance qualification and\nvalidation, site readiness, batch record reviews, authoring regulatory CTD\nsections and/or working with external contract organisation for development\nand/or manufacturing.\n\nWorking knowledge of statistical methods for DOE designand data analysis (e.g., JMP or Design Expert software)\n\nWorking knowledge of statistical process control (SPC),multivariate analysis (MVDA), and/or process analytical technologies (PAT)\ntechniques for biologics processes","description_format":"text","description_chars":6303,"description_truncated":false,"requirements":{"experience_years_min":5,"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":["Biotechnology","Health Care","Healthcare & Life Sciences Consulting"],"lifecycle":[{"event":"open","at":"2026-10-30T15:45:39Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":28,"reasons":["conf:3","win:early"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/psc-biotechr-senior-specialist-process-engineer","json_url":"https://alion.io/job/psc-biotechr-senior-specialist-process-engineer.json","meta":{"generated_at":"2026-11-01T11:20:16Z","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":17525,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":4424516},"rest":"https://alion.io/mcp/rest/get_company?id=4424516"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpsc-biotechr-senior-specialist-process-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fpsc-biotechr-senior-specialist-process-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fpsc-biotechr-senior-specialist-process-engineer"},{"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/psc-biotechr-senior-specialist-process-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpsc-biotechr-senior-specialist-process-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3529934}},{"tool":"search_jobs","arguments":{"company":"biotech.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3529934},"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. 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