{"schemaVersion":"jobsearcher.job.v1","id":"2a4ea0de7ddc0929fe5848e5","url":"https://jobsearcher.com/jobs/2a4ea0de7ddc0929fe5848e5","canonicalUrl":"https://jobsearcher.com/jobs/2a4ea0de7ddc0929fe5848e5","title":"Packaging Process Engineer - Automation & Serialization","description":"Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference.\n\nKnoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder – at no profit.\n\nPosition Summary\nThe Process Engineer provides engineering ownership and technical expertise for packaging equipment, automation systems, human‑machine interface (HMI), and serialization solutions used in Oral Solid Dosage (OSD) pharmaceutical manufacturing. This role ensures reliable, compliant, and efficient packaging operations while meeting global serialization and data integrity regulations. The engineer collaborates cross‑functionally to support daily operations, projects, validation, and continuous improvement initiatives.\n\nCore Responsibilities\n\nProvide technical support and ownership for OSD packaging equipment, including bottle lines, bundlers, bundler labelers, case packers, labelers, checkweighers, and vision systems.\n\nTroubleshoot mechanical, electrical, and controls‑related issues to minimize downtime and improve line performance.\n\nSupport equipment installation, commissioning, factory acceptance test/site acceptance test (FAT/SAT), and start‑up activities.\n\nAutomation & HMI Support\n\nSupport programmable logic controller (PLC), HMI, and supervisory control and data acquisition (SCADA) systems associated with packaging lines.\n\nConfigure and maintain HMI screens, alarms, recipes, and user access levels.\n\nTroubleshoot controls and automation issues, working closely with maintenance and automation teams.\n\nSupport automation upgrades, obsolescence management, and standardization initiatives.\n\nProvide engineering support for serialization and aggregation systems to ensure compliance with Drug Supply Chain Security Act (DSCSA).\n\nSupport integration between packaging equipment, vision systems, serialization software, site repositories, and enterprise systems.\n\nManage serialization exceptions, rework processes, aggregation hierarchy issues, and data reconciliation.\n\nEnsure data integrity and secure handling of serialized information.\n\nQualification & Validation\n\nDevelop, execute, and support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities for packaging equipment, automation systems, and serialization solutions.\n\nSupport change controls, risk assessments, and re‑validation activities related to equipment or software changes.\n\nEnsure validation documentation is accurate, compliant, and inspection‑ready.\n\nCompliance & Documentation\n\nEnsure packaging, automation, and serialization activities comply with cGMP, data integrity, and company quality standards.\n\nAuthor and review standard operating procedures (SOPs), user requirement specifications (URSs), functional specifications, validation documents, deviations, and corrective and preventative actions (CAPAs).\n\nSupport internal audits, customer audits, and regulatory inspections.\n\nIdentify and implement improvements to packaging line efficiency, automation reliability, HMI usability, and serialization performance.\n\nSupport or lead capital and improvement projects related to packaging equipment, controls, and serialization upgrades.\n\nApply lean manufacturing and operational excellence principles.\n\nCross‑Functional Collaboration\n\nPartner with Manufacturing, Quality, Validation, IT/Automation, and Supply Chain teams.\n\nProvide technical training and support for operators and maintenance personnel.\n\nInterface with equipment vendors, automation providers, and serialization vendors.\n\nEducation and Experience\nBachelor’s degree in Mechanical, Electrical, Automation, Industrial, or Chemical Engineering, or a related discipline. Associates degree will be considered with appropriate experience.\n\n6-9 years of engineering experience in pharmaceutical packaging operations, preferably in an OSD environment. Hands‑on experience with packaging equipment and line integration.\n\nKnowledge, Skills and Abilities\n\nAbility to work with and support automation systems, including PLCs and HMIs.\n\nAbility to support serialization and aggregation systems in regulated environments.\n\nKnowledge of and ability to work in compliance with cGMP requirements.\n\nKnowledge of pharmaceutical packaging operations and associated equipment.\n\nAbility to apply industrial automation concepts, including PLCs and HMIs.\n\nWorking knowledge of serialization regulations, data integrity principles, and track‑and‑trace systems.\n\nStrong ability to troubleshoot issues and perform root cause analysis.\n\nAbility to support change control, deviation management, and CAPA activities.\n\nAbility to communicate effectively through technical writing, verbal communication, and teamwork.\n\nPhysical and Environmental Requirements\n\nOccasionally move/traverse, ascend/descend step ladders, stairs, and/or platforms.\n\nWear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator). Position requires wearing a Powered Air‑Purifying Respirator (PAPR) during specific processes.\n\nOccasionally, transport materials using manual and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets.\n\nPerform cleaning and assembly/disassembly on production equipment which may require pulling, pushing, or twisting to remove equipment shields, parts, and panels. Equipment and parts may weigh up to 50 pounds.\n\nAbility to work a 10.5‑hour per day, 4‑day work week (Monday–Thursday), totaling 40 hours per week with off‑shift, weekend, or shutdown support as required.\n\nSupervisory Requirements (if applicable)\nThis position may provide functional guidance, project leadership, or mentoring to team members but does not have direct supervisory responsibility.\n\nAdditional Information\nThis job description is not intended to be an all‑inclusive list of duties and responsibilities and may be modified as business needs require.\n\nWe are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.\n\nFor more information about your rights under Equal Employment Opportunity, visit:\n\nEEOC Know Your Rights\n\nUSERRA Rights\n\nFamily and Medical Leave Act (FMLA)\n\nEmployee Polygraph Protection Act (EPPA)\n\nE-Verify (English and Spanish)\n\nRight to Work (English and Spanish)\n\nWe strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at careers@pharma.com. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.\n\nThe Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.\n\nUnder certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company’s internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.\n\n#J-18808-Ljbffr","company":"Knoa Pharma","rawCompany":"knoa pharma","city":"Wilson","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-06-20T03:40:29.941Z","occupations":[{"code":"51-9111.00","title":"Packaging and Filling Machine Operators and Tenders","slug":"packaging-and-filling-machine-operators-and-tenders"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"53-7064.00","title":"Packers and Packagers, Hand","slug":"packers-and-packagers-hand"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"561910","title":"Packaging and Labeling Services","slug":"packaging-and-labeling-services"},{"code":"333993","title":"Packaging Machinery Manufacturing","slug":"packaging-machinery-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Packaging Process Engineer - Automation & Serialization","description":"Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference.\n\nKnoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder – at no profit.\n\nPosition Summary\nThe Process Engineer provides engineering ownership and technical expertise for packaging equipment, automation systems, human‑machine interface (HMI), and serialization solutions used in Oral Solid Dosage (OSD) pharmaceutical manufacturing. This role ensures reliable, compliant, and efficient packaging operations while meeting global serialization and data integrity regulations. The engineer collaborates cross‑functionally to support daily operations, projects, validation, and continuous improvement initiatives.\n\nCore Responsibilities\n\nProvide technical support and ownership for OSD packaging equipment, including bottle lines, bundlers, bundler labelers, case packers, labelers, checkweighers, and vision systems.\n\nTroubleshoot mechanical, electrical, and controls‑related issues to minimize downtime and improve line performance.\n\nSupport equipment installation, commissioning, factory acceptance test/site acceptance test (FAT/SAT), and start‑up activities.\n\nAutomation & HMI Support\n\nSupport programmable logic controller (PLC), HMI, and supervisory control and data acquisition (SCADA) systems associated with packaging lines.\n\nConfigure and maintain HMI screens, alarms, recipes, and user access levels.\n\nTroubleshoot controls and automation issues, working closely with maintenance and automation teams.\n\nSupport automation upgrades, obsolescence management, and standardization initiatives.\n\nProvide engineering support for serialization and aggregation systems to ensure compliance with Drug Supply Chain Security Act (DSCSA).\n\nSupport integration between packaging equipment, vision systems, serialization software, site repositories, and enterprise systems.\n\nManage serialization exceptions, rework processes, aggregation hierarchy issues, and data reconciliation.\n\nEnsure data integrity and secure handling of serialized information.\n\nQualification & Validation\n\nDevelop, execute, and support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities for packaging equipment, automation systems, and serialization solutions.\n\nSupport change controls, risk assessments, and re‑validation activities related to equipment or software changes.\n\nEnsure validation documentation is accurate, compliant, and inspection‑ready.\n\nCompliance & Documentation\n\nEnsure packaging, automation, and serialization activities comply with cGMP, data integrity, and company quality standards.\n\nAuthor and review standard operating procedures (SOPs), user requirement specifications (URSs), functional specifications, validation documents, deviations, and corrective and preventative actions (CAPAs).\n\nSupport internal audits, customer audits, and regulatory inspections.\n\nIdentify and implement improvements to packaging line efficiency, automation reliability, HMI usability, and serialization performance.\n\nSupport or lead capital and improvement projects related to packaging equipment, controls, and serialization upgrades.\n\nApply lean manufacturing and operational excellence principles.\n\nCross‑Functional Collaboration\n\nPartner with Manufacturing, Quality, Validation, IT/Automation, and Supply Chain teams.\n\nProvide technical training and support for operators and maintenance personnel.\n\nInterface with equipment vendors, automation providers, and serialization vendors.\n\nEducation and Experience\nBachelor’s degree in Mechanical, Electrical, Automation, Industrial, or Chemical Engineering, or a related discipline. Associates degree will be considered with appropriate experience.\n\n6-9 years of engineering experience in pharmaceutical packaging operations, preferably in an OSD environment. Hands‑on experience with packaging equipment and line integration.\n\nKnowledge, Skills and Abilities\n\nAbility to work with and support automation systems, including PLCs and HMIs.\n\nAbility to support serialization and aggregation systems in regulated environments.\n\nKnowledge of and ability to work in compliance with cGMP requirements.\n\nKnowledge of pharmaceutical packaging operations and associated equipment.\n\nAbility to apply industrial automation concepts, including PLCs and HMIs.\n\nWorking knowledge of serialization regulations, data integrity principles, and track‑and‑trace systems.\n\nStrong ability to troubleshoot issues and perform root cause analysis.\n\nAbility to support change control, deviation management, and CAPA activities.\n\nAbility to communicate effectively through technical writing, verbal communication, and teamwork.\n\nPhysical and Environmental Requirements\n\nOccasionally move/traverse, ascend/descend step ladders, stairs, and/or platforms.\n\nWear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator). Position requires wearing a Powered Air‑Purifying Respirator (PAPR) during specific processes.\n\nOccasionally, transport materials using manual and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets.\n\nPerform cleaning and assembly/disassembly on production equipment which may require pulling, pushing, or twisting to remove equipment shields, parts, and panels. Equipment and parts may weigh up to 50 pounds.\n\nAbility to work a 10.5‑hour per day, 4‑day work week (Monday–Thursday), totaling 40 hours per week with off‑shift, weekend, or shutdown support as required.\n\nSupervisory Requirements (if applicable)\nThis position may provide functional guidance, project leadership, or mentoring to team members but does not have direct supervisory responsibility.\n\nAdditional Information\nThis job description is not intended to be an all‑inclusive list of duties and responsibilities and may be modified as business needs require.\n\nWe are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.\n\nFor more information about your rights under Equal Employment Opportunity, visit:\n\nEEOC Know Your Rights\n\nUSERRA Rights\n\nFamily and Medical Leave Act (FMLA)\n\nEmployee Polygraph Protection Act (EPPA)\n\nE-Verify (English and Spanish)\n\nRight to Work (English and Spanish)\n\nWe strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at careers@pharma.com. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.\n\nThe Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.\n\nUnder certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company’s internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T03:40:29.941Z","dateModified":"2026-06-20T03:40:29.941Z","hiringOrganization":{"@type":"Organization","name":"Knoa Pharma","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wilson","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2a4ea0de7ddc0929fe5848e5"},"url":"https://jobsearcher.com/jobs/2a4ea0de7ddc0929fe5848e5"}}