{"schemaVersion":"jobsearcher.job.v1","id":"a2cbc9d6dc313dcc6cabf670","url":"https://jobsearcher.com/jobs/a2cbc9d6dc313dcc6cabf670","canonicalUrl":"https://jobsearcher.com/jobs/a2cbc9d6dc313dcc6cabf670","title":"Operations Engineering Manager","description":"Position Summary\n\nThe Operations Engineering Manager is responsible for maintaining expertise with and making meaningful contributions to filling and related manufacturing operations to meet desired product specification for all BSM client projects of parenteral drug product manufacturing. The Operations Engineering Manager is responsible for broadly managing the novel creation of bespoke and general solutions for client-needs and / or quality parameter objections. This includes the management of staff, vendors, quality documentation, and functional requirements of process designs, implementation efficacy and training, and conception, fabrication, testing and induction of size or change part kits. The manager must be qualified for filling operations by media fill participation and contribute to contemporaneous process monitoring, improvement, and troubleshooting all fill related operations.\n\nDuties and Responsibilities\n\nWork with operations, engineering, QA, maintenance, suppliers and management to resolve problems\nWork with client to identify filling operation quality outcomes\nCommunicate with the clients and internal departments including upper management on project status and results\nPrepare and review quality documents and reports\nSuggest and partake in continuous improvement initiatives\nProvide feedback on, and propose solutions regarding process improvement initiatives to improve operating performance\nLead CAD-based part designs to empower process improvement\nDue diligence on process design and risk analysis to ensure operation safety, efficiency and quality\nReview MFG operations batch records and other quality documents and reports\nReview and approve study protocols to evaluate manufacturing processes and write associated summary reports\nCreate documents for operation and quality such as master batch records, working closely with the quality unit.\nDevelop and / or revise SOPs for equipment operations as needed\nAccurately document and record (GDP) necessary data and reports with appropriate conclusions\nComplete quality events such as deviation with sound judgement and scientific principal in a timely fashion\nMaintain expertise on equipment with many degrees of freedom and manufacturing technology changes and core process technologies\nSupport daily activities in Manufacturing Operations and be able to work flexible hours and/or remain on-call for critical operations\nCreate and maintain control charts, key performance metrics and trending data from assigned areas to communicate process controls and improvements\nEvaluate manufacturing processes and equipment and suggest improvements to increase reliability, throughput, minimize waste/rework.\nWork directly with manufacturing management to identify key areas of equipment and process improvement\nIn conjunction with manufacturing personnel, evaluate new manufacturing equipment, prepare operating procedures and develop training.\nOversee modifications to manufacturing equipment as required/requested by Manufacturing, manage associated change controls and work orders\nHave ownership of assigned equipment or business processes\nMaintain up-to-date timelines and meet agreed upon deadlines\nSource equipment and develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance and other personnel\nKeep up industry knowledge and provide trainings in equipment and manufacturing technology\nOther duties as assigned\n\nRegulatory Responsibilities\n\nConduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable\nMaintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements\n\nSupervisory Responsibilities\n\nSupervise/execute technology transfer of new processes or equipment\nSupport daily activities in the assigned areas and be able to work flexible hours and/or remain on call for critical manufacturing operations\nSupport validation activities including equipment validation and process validation\nLead problem solving and investigate quality events related to filling operations\nPropose and lead process improvement initiatives to improve operating performance\nSupervise, mentor, and develop team members or relevant personnel across departments\n\nExperience\n\nFive plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired\nIn the absence of above, 5+ years of hands-on work in a technical field performing research, or field work utilizing scientific or industrial equipment.\nThree plus (3+) years of supervisory/management experience\n\nEducation\n\nAdvanced degree expected\nMinimum of Bachelor's degree in Chemical Engineering, Chemistry, Biology, Engineering or Pharmaceutical Science AND relevant experience\n\nKnowledge, Skills & Abilities\n\nExpertise with 3D / CAD modeling and ANSI drafting\nKnowledge of scientific best practices\nExcellent in technical writing\nKnowledge of engineering first principles\nKnowledge of parenteral drug product development and manufacturing\nAble to work in a dynamic environment and adapt to changing priorities\nExcellence in solving complex engineering and / or scientific problems\nAble to handle multiple projects\nExpertise with Microsoft Office\nFamiliar with Master Control\nProject management skills\nExcellent writing skills\nAttention to detail\nWritten and oral communication skills\n\nPhysical Requirements\n\nAbility to meet gowning requirements\nAbility to remain stationary for prolonged periods of time\nAbility to periodically lift up to 50 lbs.\nSatisfactory audio-visual acuity\nGross and fine motor skills to manipulate instruments","company":"Sharp Sterile Manufacturing","rawCompany":"sharp sterile manufacturing","city":"Lee","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:41:31.259Z","occupations":[{"code":"11-1021.00","title":"General and Operations Managers","slug":"general-and-operations-managers"},{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Operations Engineering Manager","description":"Position Summary\n\nThe Operations Engineering Manager is responsible for maintaining expertise with and making meaningful contributions to filling and related manufacturing operations to meet desired product specification for all BSM client projects of parenteral drug product manufacturing. The Operations Engineering Manager is responsible for broadly managing the novel creation of bespoke and general solutions for client-needs and / or quality parameter objections. This includes the management of staff, vendors, quality documentation, and functional requirements of process designs, implementation efficacy and training, and conception, fabrication, testing and induction of size or change part kits. The manager must be qualified for filling operations by media fill participation and contribute to contemporaneous process monitoring, improvement, and troubleshooting all fill related operations.\n\nDuties and Responsibilities\n\nWork with operations, engineering, QA, maintenance, suppliers and management to resolve problems\nWork with client to identify filling operation quality outcomes\nCommunicate with the clients and internal departments including upper management on project status and results\nPrepare and review quality documents and reports\nSuggest and partake in continuous improvement initiatives\nProvide feedback on, and propose solutions regarding process improvement initiatives to improve operating performance\nLead CAD-based part designs to empower process improvement\nDue diligence on process design and risk analysis to ensure operation safety, efficiency and quality\nReview MFG operations batch records and other quality documents and reports\nReview and approve study protocols to evaluate manufacturing processes and write associated summary reports\nCreate documents for operation and quality such as master batch records, working closely with the quality unit.\nDevelop and / or revise SOPs for equipment operations as needed\nAccurately document and record (GDP) necessary data and reports with appropriate conclusions\nComplete quality events such as deviation with sound judgement and scientific principal in a timely fashion\nMaintain expertise on equipment with many degrees of freedom and manufacturing technology changes and core process technologies\nSupport daily activities in Manufacturing Operations and be able to work flexible hours and/or remain on-call for critical operations\nCreate and maintain control charts, key performance metrics and trending data from assigned areas to communicate process controls and improvements\nEvaluate manufacturing processes and equipment and suggest improvements to increase reliability, throughput, minimize waste/rework.\nWork directly with manufacturing management to identify key areas of equipment and process improvement\nIn conjunction with manufacturing personnel, evaluate new manufacturing equipment, prepare operating procedures and develop training.\nOversee modifications to manufacturing equipment as required/requested by Manufacturing, manage associated change controls and work orders\nHave ownership of assigned equipment or business processes\nMaintain up-to-date timelines and meet agreed upon deadlines\nSource equipment and develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance and other personnel\nKeep up industry knowledge and provide trainings in equipment and manufacturing technology\nOther duties as assigned\n\nRegulatory Responsibilities\n\nConduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable\nMaintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements\n\nSupervisory Responsibilities\n\nSupervise/execute technology transfer of new processes or equipment\nSupport daily activities in the assigned areas and be able to work flexible hours and/or remain on call for critical manufacturing operations\nSupport validation activities including equipment validation and process validation\nLead problem solving and investigate quality events related to filling operations\nPropose and lead process improvement initiatives to improve operating performance\nSupervise, mentor, and develop team members or relevant personnel across departments\n\nExperience\n\nFive plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired\nIn the absence of above, 5+ years of hands-on work in a technical field performing research, or field work utilizing scientific or industrial equipment.\nThree plus (3+) years of supervisory/management experience\n\nEducation\n\nAdvanced degree expected\nMinimum of Bachelor's degree in Chemical Engineering, Chemistry, Biology, Engineering or Pharmaceutical Science AND relevant experience\n\nKnowledge, Skills & Abilities\n\nExpertise with 3D / CAD modeling and ANSI drafting\nKnowledge of scientific best practices\nExcellent in technical writing\nKnowledge of engineering first principles\nKnowledge of parenteral drug product development and manufacturing\nAble to work in a dynamic environment and adapt to changing priorities\nExcellence in solving complex engineering and / or scientific problems\nAble to handle multiple projects\nExpertise with Microsoft Office\nFamiliar with Master Control\nProject management skills\nExcellent writing skills\nAttention to detail\nWritten and oral communication skills\n\nPhysical Requirements\n\nAbility to meet gowning requirements\nAbility to remain stationary for prolonged periods of time\nAbility to periodically lift up to 50 lbs.\nSatisfactory audio-visual acuity\nGross and fine motor skills to manipulate instruments","datePosted":"2026-04-14T10:41:31.259Z","dateModified":"2026-04-14T10:41:31.259Z","hiringOrganization":{"@type":"Organization","name":"Sharp Sterile Manufacturing","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Lee","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a2cbc9d6dc313dcc6cabf670"},"url":"https://jobsearcher.com/jobs/a2cbc9d6dc313dcc6cabf670"}}