{"id":2691277,"url":"https://alion.io/job/alcami-technical-operations-specialist","title":"Technical Operations Specialist","company":{"id":2280572,"name":"Alcami","domain":"alcami.com","url":"https://alion.io/company/alcami","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","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":["Clinton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":78000,"max_usd":154000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3279},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-16T09:00:26Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-16T17:44:42Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.\nAre you interested in joining our team?\nJob Summary\nThe Technical Operations Specialist supports cGMP manufacturing by providing technical oversight, troubleshooting production issues, and ensuring reliable support for both commercial and clinical operations. The Tech Ops Specialist is responsible for preparing, executing, and evaluating Continued Process Verification activities to maintain process performance and product quality. Working closely with Technical Services, Operations, Quality, Engineering, and EHS, the specialist helps drive cross-functional alignment and resolve manufacturing challenges. The position also manages the routing and tracking of critical documentation to ensure timely review and approval across departments. Additionally, the Technical Operations Specialist demonstrates leadership through training, mentoring, and supporting the development of team members.\nOn-Site Expectations\n100% on-site position.\n1st Shift: Monday - Friday, 8:00am - 5:00pm.\nResponsibilities\nManufacturing & Process Support\nSupport commercial and clinical cGMP manufacturing operations using data analysis to identify areas of improvement and overall manufacturing trends.\nTroubleshoot unexpected manufacturing events and production issues as a process SME, authoring investigations and facilitating the closure of investigations in a timely fashion.\nEnsure robust, reliable, and compliant product manufacturing. \nProcess Verification & Technical Oversight\nPrepare, execute, and evaluate Continued Process Verification (CPV) activities.\nMonitor process performance and identify opportunities for improvement. \nProvide ongoing technical support to manufacturing teams.\nCross-Functional Collaboration & Coordination\nPartner with Technical Services, Operations, Quality, Engineering, and EHS Teams to resolve documentation and manufacturing process issues resulting in CAPAs and process deviations.\nCoordinate activities to ensure alignment across manufacturing functions.\nFacilitate communication and issue resolution between departments.\nDocumentation Management & Training\nTrack and route documentation through required reviewers and approval channels, ensuring timely completion of document review and information accuracy.\nCreate and maintain standard work documents including checklists, MBRs, and MPR templates.\nAuthor Change Controls to support investigations, process changes, and equipment modifications.\nReview and approve new batch records as well as perform review of executed batch records. \nProvides training to manufacturing staff on operating procedures, batch records, and cGMP processes.\nQualifications\nAt least 5 years of experience in a pharmaceutical cGMP Manufacturing setting is required for consideration.\nRelated bachelor's degree preferred.\nMust have at least 1 year of experience in Technical Writing (deviations, SOPs, Batch Records, etc.).\nMust have demonstrated leadership and training experience. \nProficiency with Microsoft Office Suite (Word, Excel, PowerPoint) preferred.\nKnowledge, Skills, and Abilities\nAbility to drive manufacturing operations and identify/improve inefficiencies.\nAbility to work with people at all levels of the organization.\nAbility to create and interpret graphs and charts.\nAbility to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.\nAbility to interpret a variety of instructions furnished in written, oral, diagram or schedule form.\nAbility to write reports, business correspondence and procedure manuals.\nAbility to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.\nAbility to effectively present information and respond to questions from groups of managers and clients.\nBasic knowledge of computers and Microsoft Office software products.\nApplies job skills, company policies and SOPs to complete a variety of tasks.\nReceives general instructions on routine work, detailed instructions on new projects or assignments.\nPhysical Demands and Work Environment\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.\nWhile performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. 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