{"id":1684162,"url":"https://alion.io/job/abzena-process-engineer-iisr","title":"Process Engineer II/Sr","company":{"id":2138905,"name":"Abzena","domain":"abzena.com","url":"https://alion.io/company/abzena","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-03T05:45:00Z"}},"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":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":94000,"max_usd":179000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2941},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-28T19:44:52Z","employer_posted_date":"2026-08-28","last_verified_at":"2026-10-04T00:32:04Z","board_verified":true,"closed_at":null,"days_open":36,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":36},"description":"The Senior Process Engineer provides advanced process engineering support and technical leadership for GMP manufacturing operations at the Bristol, PA site. Responsibilities include technical leadership of manufacturing campaigns, complex process troubleshooting, technology transfer, process optimization, scale-up, engineering studies, and operational readiness activities.\nReporting to the Director, Process Engineering, the Senior Process Engineer works cross-functionally with Manufacturing, MSAT, Quality, Facilities & Engineering, Supply Chain, and Program Management to support safe, compliant, reliable, and effective manufacturing operations. The role serves as a senior technical subject matter expert, independently leads complex engineering activities, provides technical guidance and mentorship to less experienced engineers, and drives improvements in process performance and reliability within bioconjugation and biologics manufacturing operations.\nResponsibilities\nProcess Engineering & Manufacturing Support\nProvide advanced process engineering support for GMP manufacturing operations including bioconjugation, chromatography, filtration, formulation, and single-use processing systems.\nProvide on-floor technical leadership during manufacturing campaigns, including complex troubleshooting, technical decision support, and issue resolution.\nPartner with Manufacturing and MSAT teams to improve process robustness, throughput, yield, scalability, and execution efficiency.\nLead technical investigations related to process deviations, operational issues, and adverse process performance trends, including root cause analysis and corrective action development.\nDevelop and implement process improvements and engineering solutions that enhance operational reliability and reduce recurring manufacturing risk.\nTechnology Transfer & Scale-Up\nLead or serve as the Process Engineering technical lead for technology transfer activities from Process Development into GMP Manufacturing.\nLead process scale-up assessments, equipment fit evaluations, engineering studies, and manufacturing readiness planning.\nReview and provide technical approval or input for manufacturing records, protocols, technical documents, and process instructions to ensure readiness and technical accuracy.\nLead or provide technical oversight for process validation, PPQ activities, engineering runs, and process characterization studies.\nTechnical Leadership & Team Contribution\nServe as a senior technical resource and mentor to Process Engineers and manufacturing personnel.\nCoach less experienced engineers in troubleshooting, technical writing, investigation methodology, and GMP engineering practices.\nPromote accountability, collaboration, GMP compliance, technical rigor, and continuous improvement across engineering activities.\nIndependently prioritize complex engineering work and support the Senior Manager in coordinating technical activities aligned with manufacturing schedules and site objectives.\nQuality & Compliance\nEnsure assigned engineering activities are executed in compliance with cGMP regulations, internal procedures, and Abzena quality standards.\nLead or provide senior technical support for deviations, CAPAs, investigations, change controls, and risk assessments related to process engineering.\nParticipate in regulatory inspections and client audits as a technical SME and support preparation of technical responses.\nDrive improvements that reduce repeat deviations, strengthen process consistency, and improve technical control of manufacturing processes.\nOperational Excellence\nAnalyze process performance metrics, equipment utilization, manufacturing trends, and process capability to identify improvement opportunities.\nLead Lean and continuous improvement initiatives focused on process efficiency, waste reduction, throughput, and manufacturing effectiveness.\nDevelop and implement standardized engineering practices, technical tools, and operational improvements across manufacturing operations.\nCollaborate with Operations leadership to improve schedule adherence, campaign execution reliability, and technical readiness.\nCross-Functional Collaboration\nPartner closely with Manufacturing, MSAT, Quality, Supply Chain, Facilities & Engineering, and Program Management teams.\nSupport and, when appropriate, lead client-facing technical discussions related to manufacturing execution, investigations, process performance, and improvement plans.\nProvide technical leadership in campaign planning, operational readiness reviews, and production support activities.\nIdentify and escalate significant technical risks, operational constraints, and process concerns to the Senior Manager, Process Engineering with recommended actions.\nQualifications\nMinimum 6+ years of experience within biopharmaceutical, biologics, bioconjugation, ADC, or CDMO manufacturing environments.\nDemonstrated experience independently supporting GMP manufacturing operations and leading complex process engineering activities.\nStrong experience with technology transfer, process scale-up, process troubleshooting, data analysis, and process optimization.\nExperience leading process validation support, engineering studies, manufacturing investigations, and change implementation.\nExperience serving as a technical SME during regulatory inspections or client audits preferred.\nPreferred Qualifications\nExperience within bioconjugation, ADC, oligonucleotide, or complex biologics manufacturing environments.\nCDMO experience supporting external clients.\nExperience supporting startup operations or facility expansions.\nLean Six Sigma or continuous improvement experience preferred.","description_format":"text","description_chars":5670,"description_truncated":false,"requirements":{"experience_years_min":6,"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":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-02T10:02:46Z"}],"visa":[],"liveness":{"score":35,"band":"fade","label":"Fading","p_open":1,"p_active":0.644,"p_room":0.55,"age_days":35,"expected_fill_days":25,"reasons":["conf:3","urgency","win:tail"],"computed_at":"2026-10-03T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/abzena-process-engineer-iisr","json_url":"https://alion.io/job/abzena-process-engineer-iisr.json","meta":{"generated_at":"2026-10-04T00:43:47Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":870,"day_limit":5000,"remaining_today":4130,"minute_limit":60,"resets_at":"2026-10-05T00:00:00Z"}}}