{"schemaVersion":"jobsearcher.job.v1","id":"6aba9b343d2684df6a70d50b","url":"https://jobsearcher.com/jobs/6aba9b343d2684df6a70d50b","canonicalUrl":"https://jobsearcher.com/jobs/6aba9b343d2684df6a70d50b","title":"Sr. Process Engineer","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.\n\nAre you interested in joining our team?\n\nJob Summary\nThe Sr. Process Engineer is accountable for driving results in a fast‑paced environment by providing technical support for clinical and commercial parenteral drug product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.\n\nOn‑Site Expectations\n\n100% on‑site position.\n\n1st Shift: Monday – Friday, 8:00 am – 5:00 pm.\n\nResponsibilities\n\nProvides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.\n\nWrites Master Batch Records with a strong understanding of equipment, critical process parameters, in‑process tests, etc.\n\nMonitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.\n\nAuthors manufacturing investigations and complete CAPA assignments.\n\nComposes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.\n\nIdentifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.\n\nInteract with clients during routinely scheduled project meetings.\n\nEnsures timely completion and compliance with cGMP and all other relevant company training requirements.\n\nOther duties as assigned.\n\nQualifications\n\nBachelor’s degree in Engineering, Pharmacy, or Chemistry.\n\n5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.\n\nPrevious experience supporting tech transfer of parenteral drug products preferred.\n\nKnowledge, Skills, and Abilities\n\nExcellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem‑solving, detail orientation, organization and time‑management skills required.\n\nWorking knowledge of cGMP requirements related to sterile drug product manufacturing processes.\n\nWorking knowledge of EU regulations preferred.\n\nProficiency with Microsoft Office (Word, Excel, Outlook) required.\n\nAbility to interact with internal stakeholders and external customers.\n\nTravel Expectations\n\nUp to 5% domestic travel.\n\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 required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance; and taste or smell. The employee must frequently lift and/or move up to 25 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.\n\n#J-18808-Ljbffr","company":"Alcami","rawCompany":"alcami","city":"Columbia","state":"SC","isRemote":false,"isActive":false,"createdAt":"2026-06-21T03:30:52.560Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Process Engineer","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.\n\nAre you interested in joining our team?\n\nJob Summary\nThe Sr. Process Engineer is accountable for driving results in a fast‑paced environment by providing technical support for clinical and commercial parenteral drug product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.\n\nOn‑Site Expectations\n\n100% on‑site position.\n\n1st Shift: Monday – Friday, 8:00 am – 5:00 pm.\n\nResponsibilities\n\nProvides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.\n\nWrites Master Batch Records with a strong understanding of equipment, critical process parameters, in‑process tests, etc.\n\nMonitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.\n\nAuthors manufacturing investigations and complete CAPA assignments.\n\nComposes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.\n\nIdentifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.\n\nInteract with clients during routinely scheduled project meetings.\n\nEnsures timely completion and compliance with cGMP and all other relevant company training requirements.\n\nOther duties as assigned.\n\nQualifications\n\nBachelor’s degree in Engineering, Pharmacy, or Chemistry.\n\n5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.\n\nPrevious experience supporting tech transfer of parenteral drug products preferred.\n\nKnowledge, Skills, and Abilities\n\nExcellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem‑solving, detail orientation, organization and time‑management skills required.\n\nWorking knowledge of cGMP requirements related to sterile drug product manufacturing processes.\n\nWorking knowledge of EU regulations preferred.\n\nProficiency with Microsoft Office (Word, Excel, Outlook) required.\n\nAbility to interact with internal stakeholders and external customers.\n\nTravel Expectations\n\nUp to 5% domestic travel.\n\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 required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance; and taste or smell. The employee must frequently lift and/or move up to 25 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.\n\n#J-18808-Ljbffr","datePosted":"2026-06-21T03:30:52.560Z","dateModified":"2026-06-21T03:30:52.560Z","hiringOrganization":{"@type":"Organization","name":"Alcami","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Columbia","addressRegion":"SC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6aba9b343d2684df6a70d50b"},"url":"https://jobsearcher.com/jobs/6aba9b343d2684df6a70d50b"}}