{"id":2478296,"url":"https://alion.io/job/inteldot-specialist-manufacturing-35599","title":"Specialist Manufacturing 35599","company":{"id":4418608,"name":"Inteldot","domain":"inteldot.com","url":"https://alion.io/company/inteldot","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Breezy","truth_index":null},"role":"Operations","role_family":"Operations","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":["Juncos, Puerto Rico"],"countries":["PR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":59000,"max_usd":135000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":4991},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"ChatGPT","optional":false},{"name":"Power BI","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-09-28T15:41:31Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-30T10:08:18Z","board_verified":true,"closed_at":null,"days_open":31,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":31},"description":"Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.\nAdministrative Shift Shift: (M-F | 8am to 5pm | OT may be requested based on business needs)\nDescription:\nWith minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.\nKnowledge & Requirements:\nExperience of bio-processing unit operations. \nKnowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe). \nFamiliar with Lean Manufacturing Practices. \nAbility to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.\nProficiency in GDP (Good Documentation Practices) on a regulated environment. \nKnowledge in systems/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms. \nStrong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish. \nTeamwork Oriented. \nAble to work under minimal supervision and/or high workload and pressure. \nResponsibilities:\nInitiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.\nAssess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.\nProvide troubleshooting support.\nAssist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.\nSupport establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.\nProvide support of timely execution of the process monitoring quarterly reports.Non-Conformance and CAPA\nEnsure that all non-conformances are triaged within the established goal.\nResponsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal.\nMonitor and communicate incidents trends.\nReview equipment/system Root Cause Analysis investigations and support trend evaluations.\nAssist with generation of process validation protocols and reports and with the execution of the process validation.\nSupport collection and analysis of process validation data.\nParticipate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:\nParticipate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.\nAssess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.\nAssist manufacturing change owner on CCRB packages impacting the process.\nEducation:\nMaster’s + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience","description_format":"text","description_chars":3558,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Professional 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