{"schemaVersion":"jobsearcher.job.v1","id":"af2bbe2ed6c15aba142e9b86","url":"https://jobsearcher.com/jobs/af2bbe2ed6c15aba142e9b86","canonicalUrl":"https://jobsearcher.com/jobs/af2bbe2ed6c15aba142e9b86","title":"Pkg. Section Head","description":"Job Title: Pkg. Section Head\nFLSA Classification: Professional, Exempt\nWork Location: Fall River, MA\nWork Hours: General: 8:30AM – 5:00PM (may vary based on business needs)\nReports To: Pkg. Department Head\n\nPurpose:\nControl manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and packaging targets in time.\n\nKey Accountabilities\nAccountability Cluster\nMajor Activities / Tasks\n\nMonitor and control planned production by daily activity review as per ppackaging plan to meet packaging targets and quality standards\nReview planned production vs. actual production daily and control the production activity of the plant as per the schedule\nPrepare production schedules for the block and ensure adherence to the schedules\nEnsure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts\nEnsure execution of new product & product transfer by performing gap analysis to meet market requirements\nReview in-process analysis on daily basis to enhance the quality of final product\nMonitor unit operations and processes to avoid failures\nEnsure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue\n\nEnsure maintenance is carried out as per standards to realise optimum utilisation of manufacturing consumables\nClose maintenance issues by reviewing processes to meet production targets by coordinating with Engineering\nOptimise the utilisation of packaging consumables as per the budgets to reduce overhead cost\nConduct the daily cross functional AET meeting to continuously improve Yield, Solvent recovery, reduce OOS, OOT and complaints.\nEvaluate the requirement and ensure the availability of critical spare and consumables for the machines to avoid time loss during any machine breakdown\n\nPrepare, review and update GMP documents to meet regulatory compliance and quality of product\nPrepare the facility and rectify issues related to facility management and documentation for audit readiness\nHandle investigations, OOS, OOT, change controls, deviation & CAPA in the block\nEnsure online documentation for any non-conformance to meet GMP by performing surprise checks\nPrepare and review the qualification, validation and other documents to maintain GMP\nParticipate in the internal and external audits to assure system control\nReview new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendations\n\nEnsure adequate and trained manpower availability across shifts to ensure production continuity\nEnsure effective utilisation of manpower in each shift by understanding workload and requirement to get desired production output\nPlan and impart training on SOPs, new guidelines and policies to for achieve zero non-conformance\n\nMonitor employee and workplace safety to maintain safe environment\nEnsure all operations are performed as per safety norms to avoid accidents in plant\nEnsure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule\nConduct safety training by coordinating with HSE to promote a culture of safe working\n\nImplement packaging excellence practises for continuous improvement\nEnsure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogue\nReview the OOE data and monitor the PDCA system to minimize the losses\nTrack monthly change over time of machine to sustain the baseline\nPrepare the plans for utilization of bottleneck machines to reduce the time loss\nMonitor the yield of runner products to ensure yield above baseline\n\nMajor Challenges\nMeeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning\nKeeping up with production schedule during facility renovation and equipment upgrade\nUtilisation of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plans\nMore lead time for approval of regulatory documents by internal and external stakeholder Overcome by regular follow ups\nUnavailability of machine spares items because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare to be maintain all the time at stores for all identified machines.\nLong cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stake holder i.e. RA, R&D, LCM team and CQA, which can be overcome by defining the timelines for each stakeholder\nIssues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplier\nKey Interactions\nInternal\nExternal\n\nQuality Assurance/Control for scheduling of batches, issues in product (Daily)\nEngineering & Utility for system related queries (Daily)\nTechnical Support for troubleshooting in products (Case Basis)\nTechnology Transfer for support in new products (Project Basis)\nStores and Warehouse for RM/PM related activities (Daily)\nEHS for safety rounds and PPEs (Daily)\nCapacity panning, R&D, RA other manufacturing unit for Multiple formula harmonization and batch size optimization (Case basis).\nQA and CQA for preparation and implementation of SOP’S (Case Basis)\nIT for computerised system validation (Case Basis)\nCentral SCADA Team for Real time process data-Acquisition and control (RTPD-AC) project way forward. (Fortnightly)\nOriginal equipment manufacturers for any operation related queries and for machine spare related queries (Monthly).\nExternal Auditors during facility audits (as per schedule)\nEquipment tooling suppliers for any tool related queries and updating the performance of the tools (Case Basis).\nMaintenance contractor for Instrument calibration scheduling and its execution (Monthly).\nCivil contractor for civil work (Case Basis)\n\nKey Decisions:\nDecisions\n\nRecommendations\n\nScheduling of packaging batch\nUtilisation of packaging consumables\nIn-process checks\nManpower scheduling shift wise as per production plan and authorization of the leaves accordingly\nPackaging Plan forecast (To Plant Head)\nOOS, OOT, Complaint Investigation (To Plant Head)\nDeviation and implementation of CAPAs (To Plant Head)\nModification in plant and equipment (To Plant Head and Engineering Team)\nIdentify the products where we can increase the batch size in existing resources to enhance the plant capacity to Plant Head\nDevelopment of cost-effective alternate vendors for tools and equipment accessories to Plant Head\nModification in qualification document to Plant Head\n\nEducation and Experience\nBachelor’s degree, or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.\nMinimum of five to nine (5-9) years’ experience in formulation manufacturing with understanding of manufacturing procedures, cGMP and systems related documentation in a cGMP pharmaceutical operation environment.\n\nTechnical Knowledge and Computer Systems Skills\nUnderstanding of machines used in pharmaceutical manufacturing.\nMust be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.\nEffective interpersonal relationship skills and the ability to work in a team environment.\nCapable of conducting troubleshooting, investigations and root cause identification and analysis.\nCapable of handling and participating in compliance and regulatory audits at the local and federal levels.\nMust be proficient in computer skills and software applications such as Microsoft Office tools.\nExperience using SAP business system and applications is a plus.\nExperience in Inhalation products (MDI) is a plus.\n\nProfessional and Behavioral Competencies\nProficiently speak English as a first or second language.\nMust be a self-starter and demonstrate initiative to seek additional training or direction as needed.\nMust be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.\nKnowledge of good manufacturing practices and good documentation practices preferred.\nAbility to read, write and communicate effectively.\nSelf-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.\nExcellent organizational skills with the ability to focus on details.\n\nWork Schedule and Other Position Information:\nMust be willing to work in a pharmaceutical manufacturing setting.\nMust be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.\nMust be willing to work some weekends based on business needs as required by management.\nRelocation negotiable.\nNo remote work available.\nWorking condition\nThis role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.\nThe role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.\n#INDQU","company":"Aequora6ad214d","rawCompany":"aequora6ad214d","city":"Fall River","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-04T00:23:54.092Z","occupations":[{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"},{"code":"51-9111.00","title":"Packaging and Filling Machine Operators and Tenders","slug":"packaging-and-filling-machine-operators-and-tenders"},{"code":"51-1011.00","title":"First-Line Supervisors of Production and Operating Workers","slug":"first-line-supervisors-of-production-and-operating-workers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"561910","title":"Packaging and Labeling Services","slug":"packaging-and-labeling-services"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Pkg. Section Head","description":"Job Title: Pkg. Section Head\nFLSA Classification: Professional, Exempt\nWork Location: Fall River, MA\nWork Hours: General: 8:30AM – 5:00PM (may vary based on business needs)\nReports To: Pkg. Department Head\n\nPurpose:\nControl manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and packaging targets in time.\n\nKey Accountabilities\nAccountability Cluster\nMajor Activities / Tasks\n\nMonitor and control planned production by daily activity review as per ppackaging plan to meet packaging targets and quality standards\nReview planned production vs. actual production daily and control the production activity of the plant as per the schedule\nPrepare production schedules for the block and ensure adherence to the schedules\nEnsure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts\nEnsure execution of new product & product transfer by performing gap analysis to meet market requirements\nReview in-process analysis on daily basis to enhance the quality of final product\nMonitor unit operations and processes to avoid failures\nEnsure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue\n\nEnsure maintenance is carried out as per standards to realise optimum utilisation of manufacturing consumables\nClose maintenance issues by reviewing processes to meet production targets by coordinating with Engineering\nOptimise the utilisation of packaging consumables as per the budgets to reduce overhead cost\nConduct the daily cross functional AET meeting to continuously improve Yield, Solvent recovery, reduce OOS, OOT and complaints.\nEvaluate the requirement and ensure the availability of critical spare and consumables for the machines to avoid time loss during any machine breakdown\n\nPrepare, review and update GMP documents to meet regulatory compliance and quality of product\nPrepare the facility and rectify issues related to facility management and documentation for audit readiness\nHandle investigations, OOS, OOT, change controls, deviation & CAPA in the block\nEnsure online documentation for any non-conformance to meet GMP by performing surprise checks\nPrepare and review the qualification, validation and other documents to maintain GMP\nParticipate in the internal and external audits to assure system control\nReview new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendations\n\nEnsure adequate and trained manpower availability across shifts to ensure production continuity\nEnsure effective utilisation of manpower in each shift by understanding workload and requirement to get desired production output\nPlan and impart training on SOPs, new guidelines and policies to for achieve zero non-conformance\n\nMonitor employee and workplace safety to maintain safe environment\nEnsure all operations are performed as per safety norms to avoid accidents in plant\nEnsure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule\nConduct safety training by coordinating with HSE to promote a culture of safe working\n\nImplement packaging excellence practises for continuous improvement\nEnsure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogue\nReview the OOE data and monitor the PDCA system to minimize the losses\nTrack monthly change over time of machine to sustain the baseline\nPrepare the plans for utilization of bottleneck machines to reduce the time loss\nMonitor the yield of runner products to ensure yield above baseline\n\nMajor Challenges\nMeeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning\nKeeping up with production schedule during facility renovation and equipment upgrade\nUtilisation of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plans\nMore lead time for approval of regulatory documents by internal and external stakeholder Overcome by regular follow ups\nUnavailability of machine spares items because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare to be maintain all the time at stores for all identified machines.\nLong cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stake holder i.e. RA, R&D, LCM team and CQA, which can be overcome by defining the timelines for each stakeholder\nIssues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplier\nKey Interactions\nInternal\nExternal\n\nQuality Assurance/Control for scheduling of batches, issues in product (Daily)\nEngineering & Utility for system related queries (Daily)\nTechnical Support for troubleshooting in products (Case Basis)\nTechnology Transfer for support in new products (Project Basis)\nStores and Warehouse for RM/PM related activities (Daily)\nEHS for safety rounds and PPEs (Daily)\nCapacity panning, R&D, RA other manufacturing unit for Multiple formula harmonization and batch size optimization (Case basis).\nQA and CQA for preparation and implementation of SOP’S (Case Basis)\nIT for computerised system validation (Case Basis)\nCentral SCADA Team for Real time process data-Acquisition and control (RTPD-AC) project way forward. (Fortnightly)\nOriginal equipment manufacturers for any operation related queries and for machine spare related queries (Monthly).\nExternal Auditors during facility audits (as per schedule)\nEquipment tooling suppliers for any tool related queries and updating the performance of the tools (Case Basis).\nMaintenance contractor for Instrument calibration scheduling and its execution (Monthly).\nCivil contractor for civil work (Case Basis)\n\nKey Decisions:\nDecisions\n\nRecommendations\n\nScheduling of packaging batch\nUtilisation of packaging consumables\nIn-process checks\nManpower scheduling shift wise as per production plan and authorization of the leaves accordingly\nPackaging Plan forecast (To Plant Head)\nOOS, OOT, Complaint Investigation (To Plant Head)\nDeviation and implementation of CAPAs (To Plant Head)\nModification in plant and equipment (To Plant Head and Engineering Team)\nIdentify the products where we can increase the batch size in existing resources to enhance the plant capacity to Plant Head\nDevelopment of cost-effective alternate vendors for tools and equipment accessories to Plant Head\nModification in qualification document to Plant Head\n\nEducation and Experience\nBachelor’s degree, or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.\nMinimum of five to nine (5-9) years’ experience in formulation manufacturing with understanding of manufacturing procedures, cGMP and systems related documentation in a cGMP pharmaceutical operation environment.\n\nTechnical Knowledge and Computer Systems Skills\nUnderstanding of machines used in pharmaceutical manufacturing.\nMust be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.\nEffective interpersonal relationship skills and the ability to work in a team environment.\nCapable of conducting troubleshooting, investigations and root cause identification and analysis.\nCapable of handling and participating in compliance and regulatory audits at the local and federal levels.\nMust be proficient in computer skills and software applications such as Microsoft Office tools.\nExperience using SAP business system and applications is a plus.\nExperience in Inhalation products (MDI) is a plus.\n\nProfessional and Behavioral Competencies\nProficiently speak English as a first or second language.\nMust be a self-starter and demonstrate initiative to seek additional training or direction as needed.\nMust be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.\nKnowledge of good manufacturing practices and good documentation practices preferred.\nAbility to read, write and communicate effectively.\nSelf-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.\nExcellent organizational skills with the ability to focus on details.\n\nWork Schedule and Other Position Information:\nMust be willing to work in a pharmaceutical manufacturing setting.\nMust be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.\nMust be willing to work some weekends based on business needs as required by management.\nRelocation negotiable.\nNo remote work available.\nWorking condition\nThis role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.\nThe role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.\n#INDQU","datePosted":"2026-08-04T00:23:54.092Z","dateModified":"2026-08-04T00:23:54.092Z","hiringOrganization":{"@type":"Organization","name":"Aequora6ad214d","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Fall River","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"af2bbe2ed6c15aba142e9b86"},"url":"https://jobsearcher.com/jobs/af2bbe2ed6c15aba142e9b86"}}