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AbbVie jobs in Waco, TX - 35 jobs

  • Packaging Operator III, UD Pack, B2 7PM-7:30AM

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Perform production line duties required to meet production goals while complying with quality standards and safety requirements. Operate production equipment and complete documentation in accordance with cGMP's and department SOP's while monitoring product to ensure quality standards are maintained. **This role is for the B2 Shift: 7PM-7:30AM Wednesday/Thursday/Friday & every other Saturday Job Details This position is responsible for one or more of the following duties or activities (See individual department areas in this document for specific accountabilities): Maintain a clean and organized work area during and at the end of each shift. Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. Perform all assigned duties according to departmental SOP's and cGMP's. Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department. Complete and remain current with all required cGMP and safety training. Perform tasks in the production / packaging of product to provide on-time delivery to customers. Complete all required documentation associated with the production and / or packaging of product. Assist daily production in operating and monitoring technical, computerized, production machinery, ensuring quality standards are maintained. Perform other duties as assigned Qualifications Education and Experience: Minimum requirements for this position are: Education - High School degree or equivalent. Experience: Technical - Previous experience working in a manufacturing setting preferred. Previous experience with high speed production lines and equipment preferred. Experience: Regulatory - Experience working in a GMP regulated environment preferred. Experience: Aseptic - Experience working in an Aseptic Production environment preferred. Essential Knowledge, Skills & Abilities: Detail-oriented and self-motivated Excellent hand-eye coordination and manual dexterity. Excellent math skills; ability to add, subtract, multiply, and divide. Ability to read, comprehend, write, and communicate effectively in English. Ability to carry out detailed written or oral instructions. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Ability to work any shift (up to 12-hours) as required dependent on business needs. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $31k-36k yearly est. 23d ago
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  • Manufacturing Technician II, Compounding, B1 (6AM-6:30PM)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Responsible for compounding high-quality solutions, semi-solids, and suspensions in accordance with Good Manufacturing Practices (GMP) and department Standard Operating Procedures (SOP). This is a B1 Shift- 6AM-6:30PM Thursday/Friday/Saturday & every other Wednesday Job Details This position is responsible for the following: Accurate formulation of products. Stage, load, operate, and monitor all equipment for product formulations. Weighing and mixing chemicals according to specific formulas. Calibrate, operate, and monitor all formulation-related equipment (e.g., mixers, scales, meters, etc.). Perform operations necessary to adjust the pH of product for in-process testing. Clean, steam, and sanitizes all tanks, facilities, equipment and chemical containers used in the product formulation process in accordance with current SOP's and cGMP's. Accurately complete documents and record production volumes (batches) in compliance with current GDP standards. Assumes other duties and responsibilities, as necessary, within the Compounding department, in an effort to provide the required support to ensure adherence to the production schedule. Qualifications Education and Experience: Minimum requirements for this position are: Education - High School Diploma or GED equivalent. Associate's Degree preferred with coursework in the Sciences. Experience - Bulk manufacturing or product manufacturing experience highly preferred Experience: Technical - At least two (2) years related work experience, preferably in a high-speed production or manufacturing environment. Experience: Regulatory - Experience working in a GMP regulated environment preferred. Experience: Systems - Basic user knowledge of Microsoft Office, SAP experience preferred. Experience: Aseptic - Experience working in an Aseptic Production environment preferred. Essential Knowledge, Skills & Abilities: Ability to perform detailed tasks and document activities completely and accurately. Ability to think and plan in a logical sequential order. Able to work in a controlled environment that includes surgical mask and goggles. Ability to comply with gowning validation and subsequent gowning verifications. Ability to work any shift (up to 12-hours) as required dependent on business needs. Capable of standing for long periods of time. Capable of using hands to feel objects, use tools or controls and reach with hands and arms. Ability to read, comprehend, write, and communicate effectively in English. Ability to carry out detailed written or oral instructions. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. Basic user knowledge and understanding of Windows-based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Physically able to continuously stand and walk. Physically able to lift up to 40 lbs. Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $42k-52k yearly est. 22h ago
  • Aseptic Site Trainer

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description The Aseptic Site Trainer is responsible for assisting in the coordination of delivery of high-quality educational services and solutions. Aseptic Site Trainer provides administrative support in the implementation of training programs and in the ongoing facilitation and tracking of training initiatives and requirements. This position involves close collaboration with leaders and associates throughout the organization to ensure that educational solutions are accurate, comprehensive, and applicable to the needs of the business. Responsibilities: + Ensure AbbVie Training Policy, process and procedures and regulatory training requirements are implemented at the site. + Train new and existing employees on appropriate cleanroom behavior and best practices including but not limited to activities such as equipment intervention and sampling. + Supports implementation of global Aseptic Best Practices related to aseptic processes and training + Create content and administer periodic refresher training for employees working in the cleanroom areas + Create and revise procedures, as needed, related to job function + Identify areas of improvement with current aseptic processes at the site and manage continued improvement projects, as needed. + Observe employees aseptic gowning technique and provide coaching. + Additional aseptic related projects, as assigned by department management + Maintain a working knowledge of operations processes. Actively recommend, support, and facilitate continuous improvement projects to increase the effectiveness of training system. + Generate various training status tracking reports, present reports to site management. + Gowning Training (initial and recertification) + Partner with Microbiology and Operations for Environmental Monitoring and Sanitization Training + Monthly shift touchpoints focused on a pre-established rolling Aseptic refresher (target 15-20 min 10 topics, conducted when semi-annual refresher training is not performed) + Monthly Gemba walks with Aseptic MQA / site leadership + 20% of time dedicated to Aseptic Auditing + Work with global Aseptic Trainers to develop, then deliver targeted aseptic trainings based on site needs + This position will support the entire site for aseptic training. It will be working with the global staff to identify and help roll out additional training if required. Gemba walks and on the floor training reinforcement. Qualifications + Bachelor's degree required. Degree program or professional certification in Education, Communication, Training, or a related field is beneficial. + Knowledge of regulations and standards for Aseptic manufacturing and application to training. + At least 3 years of Aseptic Operations/Quality/Training, combined experience is required. + Essential experience should include knowledge of GMPs, aseptic manufacturing, and training processes. + Strong oral and excellent written communication skills; excellent organizational skills + Strong computer skills necessary, including Microsoft Windows and Office applications + Ability to independently manage multiple tasks/assignments, meet deadlines and act with flexibility and initiative to thrive in a dynamic environment of rapidly changing needs. + Ability to effectively interact and develop constructive and cooperative relationships with subject matter experts and other business partners Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $64,000 - $122,000 + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $82,500 - $157,500
    $82.5k-157.5k yearly 60d+ ago
  • Site Compliance Manager

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description Purpose Manages Quality Engineers and Quality Trainer engaged in activities to support Product Surveillance for Medical Devices and Combination products. The Global Compliance Manager is responsible for the management and coordination of a team of Quality Engineers and Quality Trainer. Manages project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to: Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site's internal audits. Oversees internal, supplier and regulatory audits and preparation activities. Responsibilities + Responsible for Quality System and Compliance investigations and support for processing of complaint/adverse event files following global complaint handling regulations, device tracking, clinical protocol data intake and internal procedures. Ability to analyze current processes and information obtained and make decisions for reportability under 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance regulations. + Conduct, review and approve CAPA and Non-Conformance investigations. Monitor and support Quality Engineers approving investigations. Responsible for CAPA and Non-Conformance program for Global Product Surveillance. + Oversees development of departmental metrics for AbbVie's local and segment management reviews and ad hoc requests. + Oversees supplier quality compliance to support complaint handling in accordance with AbbVie policies. + Assess opportunities for interdepartmental and site harmonization of practices and interruption of quality system requirements. + Review and Approve documents pertaining to department Quality Systems (SOPs, DOPs, forms, etc.). + Provide generalized Quality System, company, departmental and product knowledge as required. + Collect data and analyze as required to support inquiries from Regulatory bodies, internal and external customers. + Monitor department processes and workflow compliance to regulatory and department procedures and policies and for opportunities for improvement and optimization. + Responsible for Regulatory audit preparation and execution. Host audits on site and travel to other sites to support audits and inspections as needed. Maintain internal audits schedule and organize audits to self-identify compliance non-conformities. Provide leadership and design for back room audit support activities and document reviews. Qualifications + Bachelor's degree (scientific degree preferred) and seven to eight years related experience and/or training in a regulated industry (Pharmaceutical, Medical Device, Nuclear, etc..) or in a medical environment. Supervisory experienced preferred but not required. + Knowledge of applicable regulations including, but not limited to, 21 CFR 803, 21 CFR 820, 21 CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and other international complaint handling and vigilance regulations. + Experience in TrackWise and eLMS preferred. + Ability to communicate and collaborate with other departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, and Marketing departments to ensure corporate goals and strategies are met. + Ability to initiate or suggest plans to motivate workers to achieve work goals. + Ability to provide accurate and complete information in a prompt manner. + Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities. + Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. + This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $106,500 - $202,500
    $106.5k-202.5k yearly 60d+ ago
  • Equipment Technician IV, Tuesday- Saturday (6PM-2:30AM)

    Abbvie, Inc. 4.7company rating

    Abbvie, Inc. job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Perform Maintenance duties required to support production goals while complying with quality standards and safety requirements. Diagnose production and / or packaging equipment to determine repair needs. Perform repairs in a timely manner and complete all required documentation in accordance with cGMP's and department SOP's. Maintain equipment functionality through the preventative maintenance program. Job Details This position is responsible for the following: * Maintain a clean and organized work area during and at the end of each shift. * Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. * Performs all assigned duties according to departmental SOP's and cGMP's. * Remains current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department. * Completes and remains current with all required cGMP and safety training. * Performs maintenance and repairs of production / packaging equipment to support the on-time delivery to customers, with a minimum amount of downtime. * Assist with set-up and changeovers of production / packaging equipment. * Troubleshoots equipment and coordinate corrective actions to reduce or eliminate defects, rejects, or equipment downtime. * Completes all required documentation associated with the repair and maintenance of production and / or packaging equipment. * Provides guidance and training to less experienced mechanics to ensure PM's, line set-up and changeovers are performed within established requirements. Qualifications Minimum requirements for this position are: Education - Two-year Associate's Degree in Industrial Maintenance, Industrial Systems, Instrumentation, Electrical Systems, Electronics or similar field with a minimum of two (2) - three (3) years of experience in industrial maintenance performing mechanical/electrical repairs OR High School diploma or GED equivalent with three (3) - five (5) years of experience in industrial maintenance performing mechanical/electrical repairs. Experience: Technical - Mastery in Electrical & Mechanical Troubleshooting. Proficiency in Maintenance Methods. Proficiency with multiple types of industrial manufacturing equipment. Experience: Regulatory - Experience working in a cGMP or FDA regulated manufacturing environment preferred. Essential Knowledge, Skills & Abilities: * Detail-oriented and self-motivated * Excellent hand-eye coordination and manual dexterity. * Excellent math skills; ability to add, subtract, multiply, and divide. * Ability to read, comprehend, write, and communicate effectively in English. * Ability to carry out detailed written or oral instructions. * Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. * Basic user knowledge and understanding of Windows-based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. * Physically able to continuously stand and walk. * Physically able to lift up to 40 lbs. for men and 35 lbs. for women. * Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently. * Knowledge of manual and automated production / packaging equipment. * Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment. * Ability to apply troubleshooting principles with industrial equipment. * Working knowledge of Filling/Packaging equipment. * Must be able to work independently and with minimal supervision. * Ability to read Electrical and Mechanical manuals and schematics. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $56k-72k yearly est. 60d+ ago
  • Manufacturing Supervisor II, MD Fill- A1 Shift 6AM-6:30PM

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description The role of the Manufacturing Supervisor II has knowledge and experience in its field while still building expertise. Is expected to work autonomously with little or no direct supervision. Lead and facilitate safe operations in line with all safety, regulatory and operational requirements. Assure the long-term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. *This is an A1 Shift role: 6AM-6:30PM Sunday/Monday/Tuesday & every other Wednesday Responsibilities + Safety: Create an environment where safety is the number one priority in every activity that you do, driving safety improvements and conducting safety gembas routinely. Be present on the floor promoting a culture of zero safety incidents in compliance with all EHS requirements. + People: Responsible for daily effective deployment of team members and ensure tasks are appropriately delegated to meet the production schedule. Ensure that team members are trained to the required standards of their job. Drives engagement with team by having regular 1:1s, conducts performance reviews and has survey actions plans in place. Ensure time and attendance is approved on time each week so that employees are paid correctly. Communicating effectively with team cascading important info. + Operational: Provides assistance in developing weekly goals and production schedules to determine unit assignments and critical actions with little or no supervision. Responsible for the effective coordination of the activities within the shift to meet the production schedule. Ensure a smooth shift handover with the next manager to ensure departmental activities are planned and executed safely. + Compliance: Ensure compliance with applicable regulatory agencies. Implement a proactive compliance management process where material checks, line clearance checks and spot checks are conducted routinely. Effectively manage any compliance issue that arises during shift that could potentially impact on lot completion. + Performance: Responsible for change-over time management and complete cycle time management. Continuously seeks to identify improvements and supports the implementation of process improvement projects. Responsible for managing resources across all of production to maximize shift throughput. Accountable for overall shift training program (where applicable).Knows all metrics and actively supports initiatives to ensure their area meets expectations and targets. + Development: Be proactive in self-development by having a growth mindset towards personal development. Ensures all employees in their organization have development action/ plans in place and arranging opportunities for growth. + Operation Excellence (OpEx): Participates in process improvement initiatives. Qualifications Qualifications + Bachelor's degree is required. A degree in sciences or engineering is preferred. A minimum 2 years experience supervising or leading a functional team. Experience in regulated pharmaceutical industry is strongly preferred. + Experience: Systems - Proficient in Microsoft Office and other manufacturing systems, such as SAP. Familiarity with industrial automation (distributed control and PLC based systems). Experience in cross functional process improvement initiatives is preferred. + Experience: Regulatory- Working knowledge of safety, quality systems, and cGMPs is required. + Experience: Aseptic (If applicable) -Experience working in an aseptic production environment preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $82,500 - $157,500
    $82.5k-157.5k yearly 38d ago
  • Senior Global Manufacturing Execution Systems Engineer

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Purpose : The Manufacturing Execution Systems Engineer will design, implement, and optimize Manufacturing Execution System (MES) solutions across AbbVie's global manufacturing network, directly supporting the MES COE Lead's strategic vision for digital transformation and operational excellence. Responsibilities: •Collaborate with the Manager, MES and cross-functional teams to deliver high-quality MES solutions aligned with enterprise strategy and standards. •Lead technical design, configuration, integration, and testing of MES applications for multiple manufacturing modalities and sites •Develop, document, and maintain MES best practices, playbooks, and standard operating procedures (SOPs). •Lead Communities of Practice (COP) meetings across AbbVie's processes and Champion template standardization and process simplification using advanced MES capabilities. •Provide technical leadership and mentorship to MES engineers and collaborators. •Support Adoption of New MES technology and digital transformation initiatives at the site and network levels. •Analyze manufacturing processes and data to identify areas for MES-driven process improvement, automation, and harmonization. •Ensure compliance with cGMP, regulatory requirements, and AbbVie's ways of working in all MES engineering activities. •Contribute to governance, technical documentation, and training programs for MES solutions. Support New Instance MES program delivery through Global Recipe Templates. Engage with internal and external partners (technology, automation, operations, IT) to support MES initiatives and continuous improvement. •Responsible for delivering high-quality MES engineering solutions that achieve strategic and operational goals set by the COE Lead. Maintains high standards of process compliance and actively supports a culture of innovation and continuous improvement in MES operations. . Qualifications •Bachelor's degree in Software Engineering, Science, IT, or related field. •6+ years experience with Manufacturing Execution Systems (MES) in pharmaceutical manufacturing, automation, or regulated environments. •Solid understanding of digital manufacturing concepts, MES technology operation, and enterprise IT/OT integration. •Experience with process improvement, system analysis, and technical documentation in multi-site/global environments. •Demonstrated ability to work collaboratively in multi-disciplinary teams and communicate effectively across business and technology. •Working knowledge of cGMP, pharma regulatory standards, and quality compliance. •Experience with MES platforms preferably POMS Aquila •Ability to train/mentor junior staff and contribute to knowledge sharing across the network. •Strong problem-solving, analytical, and organizational skills. . Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $101k-126k yearly est. 22h ago
  • Senior Engineer, Onsite, Waco, TX (Onsite)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description An engineering professional who, working with little or no supervision, applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline. A Senior Engineer has general knowledge of other related disciplines beyond their own area of expertise. Responsibilities: + Responsibilities of this engineering grade level inherently include and expand upon the responsibilities established for lower engineering grade levels. + Collaborates with multiple departments to assess and develop corrective and preventative actions (CAPA) for non-conformance reports (NCR) related to issues with process or product when procedures or policy requirements are not met. + Responsible for compliance with applicable policies and procedures. + Independently plans and conducts investigations . Manages multiple, often concurrent, investigations and meets deadlines. Responsible for achieving investigation completion targets in support of business objectives. Balances multiple demands. + Represents Technical Operations Investigations on root cause analysis (RCA) task forces. Identifies full range of customer/client needs and proposes solutions to address them. Qualifications + Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 5+ years of significant engineering and/or operational experience. + Has demonstrated competency within a discipline. + Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Demonstrates judgment within defined procedures and practices to determine appropriate action. + Interacts well with diverse groups within manufacturing operations and QA and maintains strong working relationships with internal and external collaborators. + Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations. + Works well with other colleagues in a collaborative, fast-paced goal-driven environment. + Possesses interpersonal skills to negotiate and reconcile differences. + Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred). + Has demonstrated competency with financial systems and in fiscal control. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $82,500 - $157,500
    $82.5k-157.5k yearly 32d ago
  • QC Lab Supervisor I (Tuesday-Saturday 2pm-10pm)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description The QC Lab Supervisor I is responsible for the organization, administration, and supervision of Lab Analysts and other Lab employees; properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. Oversees the processes of the chemical analysis and release of raw materials, in-process, and final products in compliance with current quality criteria while respecting deadlines and managing costs. Ensures effective and efficient utilization of laboratory resources through management of laboratory support activities. + Responsible for leading and developing a high performing team while prioritizing shop floor presence. This includes hiring, setting performance expectations, providing continuous and on-time performance feedback, coaching staff, assisting in problem-solving, and handling employee matters. Ensures that the department has the appropriate talent and level of performance to meet business objectives. Monitors administration of training, identifies training needs, and ensures development of team. + Oversees the operation and functions of the laboratory group which may include Raw Materials, Finished Products, Projects/validation samples, MEC, and stability samples. Organizes laboratory activity by coordinating the activity of personnel depending on the demands of planning. Controls the products (raw materials, intermediates, and finished products) by following procedures (general, specific, of analysis and use, and qualification of equipment) to meet the lab testing schedule. Oversees s + Identifies aspects of the tests or results warranting further attention and implements corrective actions. + Reviews and approves Analytical data (may relate to analytical product release depending on regional regulatory requirements). + Supports laboratory investigations, including out-of-specification test results, and ensures effective corrective actions are implemented. + Effectively understands, communicates, and presents QC Metrics. Attends and leads Tier meetings. + Ensures appropriate procedures are in place and that QC activities are executed in line with internal procedures, requirements of cGMP, and relevant safety standards. Assists in implementing continuous improvement actions to lab processes. + Assists analysts with analytical/microbial instrumentation. Assures instrumentation availability to achieve schedule and improves capacity by ensuring that preventive and repair maintenance as well as material qualifications are carried out in a timely matter. Plans the needs of instruments by maintaining permanent technical and technological intelligence. Applies systematic corrections and/or corrective actions that mitigate the risk of recurrent instrumentation failures. + Assists in the periodic inspection of laboratory facilities to ensure that they are operated and administered according to Good Manufacturing Practices (GMP) and Good Laboratory Practices, maintaining laboratory audit readiness. When required, support supplier, internal, and regulatory audits + May serve as a backup when the Lab Manager is unavailable. Qualifications + Bachelor's Degree required, preferably in a Scientific field (Chemistry, Microbiology, or Biology) + 2+ years of QC Lab experience required. + Demonstrated thorough scientific knowledge and technical expertise in chemistry, technical writing, investigations, analytical laboratory equipment, and laboratory operations required. + General knowledge in cGMPs, compendia, and regulations required + Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required. Ability to foster an inclusive environment. + Ability to work cross-functionally and coordinate work both within the department and with other departments. + Ability to interpret the impact of laboratory data for appropriate and effective actions. + Ability to identify, develop, communicate, and follow through to completion necessary corrective action plans to resolve problems. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $82,500 - $157,500
    $82.5k-157.5k yearly 60d+ ago
  • Aseptic Site Trainer

    Abbvie, Inc. 4.7company rating

    Abbvie, Inc. job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Aseptic Site Trainer is responsible for assisting in the coordination of delivery of high-quality educational services and solutions. Aseptic Site Trainer provides administrative support in the implementation of training programs and in the ongoing facilitation and tracking of training initiatives and requirements. This position involves close collaboration with leaders and associates throughout the organization to ensure that educational solutions are accurate, comprehensive, and applicable to the needs of the business. Responsibilities: * Ensure AbbVie Training Policy, process and procedures and regulatory training requirements are implemented at the site. * Train new and existing employees on appropriate cleanroom behavior and best practices including but not limited to activities such as equipment intervention and sampling. * Supports implementation of global Aseptic Best Practices related to aseptic processes and training * Create content and administer periodic refresher training for employees working in the cleanroom areas * Create and revise procedures, as needed, related to job function * Identify areas of improvement with current aseptic processes at the site and manage continued improvement projects, as needed. * Observe employees aseptic gowning technique and provide coaching. * Additional aseptic related projects, as assigned by department management * Maintain a working knowledge of operations processes. Actively recommend, support, and facilitate continuous improvement projects to increase the effectiveness of training system. * Generate various training status tracking reports, present reports to site management. * Gowning Training (initial and recertification) * Partner with Microbiology and Operations for Environmental Monitoring and Sanitization Training * Monthly shift touchpoints focused on a pre-established rolling Aseptic refresher (target 15-20 min 10 topics, conducted when semi-annual refresher training is not performed) * Monthly Gemba walks with Aseptic MQA / site leadership * 20% of time dedicated to Aseptic Auditing * Work with global Aseptic Trainers to develop, then deliver targeted aseptic trainings based on site needs * This position will support the entire site for aseptic training. It will be working with the global staff to identify and help roll out additional training if required. Gemba walks and on the floor training reinforcement. Qualifications * Bachelor's degree required. Degree program or professional certification in Education, Communication, Training, or a related field is beneficial. * Knowledge of regulations and standards for Aseptic manufacturing and application to training. * At least 3 years of Aseptic Operations/Quality/Training, combined experience is required. * Essential experience should include knowledge of GMPs, aseptic manufacturing, and training processes. * Strong oral and excellent written communication skills; excellent organizational skills * Strong computer skills necessary, including Microsoft Windows and Office applications * Ability to independently manage multiple tasks/assignments, meet deadlines and act with flexibility and initiative to thrive in a dynamic environment of rapidly changing needs. * Ability to effectively interact and develop constructive and cooperative relationships with subject matter experts and other business partners Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $64,000 - $122,000 * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $64k-122k yearly 4d ago
  • Site Compliance Manager

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Purpose Manages Quality Engineers and Quality Trainer engaged in activities to support Product Surveillance for Medical Devices and Combination products. The Global Compliance Manager is responsible for the management and coordination of a team of Quality Engineers and Quality Trainer. Manages project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to: Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site's internal audits. Oversees internal, supplier and regulatory audits and preparation activities. Responsibilities Responsible for Quality System and Compliance investigations and support for processing of complaint/adverse event files following global complaint handling regulations, device tracking, clinical protocol data intake and internal procedures. Ability to analyze current processes and information obtained and make decisions for reportability under 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance regulations. Conduct, review and approve CAPA and Non-Conformance investigations. Monitor and support Quality Engineers approving investigations. Responsible for CAPA and Non-Conformance program for Global Product Surveillance. Oversees development of departmental metrics for AbbVie's local and segment management reviews and ad hoc requests. Oversees supplier quality compliance to support complaint handling in accordance with AbbVie policies. Assess opportunities for interdepartmental and site harmonization of practices and interruption of quality system requirements. Review and Approve documents pertaining to department Quality Systems (SOPs, DOPs, forms, etc.). Provide generalized Quality System, company, departmental and product knowledge as required. Collect data and analyze as required to support inquiries from Regulatory bodies, internal and external customers. Monitor department processes and workflow compliance to regulatory and department procedures and policies and for opportunities for improvement and optimization. Responsible for Regulatory audit preparation and execution. Host audits on site and travel to other sites to support audits and inspections as needed. Maintain internal audits schedule and organize audits to self-identify compliance non-conformities. Provide leadership and design for back room audit support activities and document reviews. Qualifications Bachelor's degree (scientific degree preferred) and seven to eight years related experience and/or training in a regulated industry (Pharmaceutical, Medical Device, Nuclear, etc..) or in a medical environment. Supervisory experienced preferred but not required. Knowledge of applicable regulations including, but not limited to, 21 CFR 803, 21 CFR 820, 21 CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and other international complaint handling and vigilance regulations. Experience in TrackWise and eLMS preferred. Ability to communicate and collaborate with other departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, and Marketing departments to ensure corporate goals and strategies are met. Ability to initiate or suggest plans to motivate workers to achieve work goals. Ability to provide accurate and complete information in a prompt manner. Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities. Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $99k-124k yearly est. 22h ago
  • Equipment Technician IV, MD Fill (5:30PM-6:00AM)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Perform Maintenance duties required to support production goals while complying with quality standards and safety requirements. Diagnose production and / or packaging equipment to determine repair needs. Perform repairs in a timely manner and complete all required documentation in accordance with cGMP's and department SOP's. Maintain equipment functionality through the preventative maintenance program. This role is 5:30PM-6:00AM Sunday, Monday, Tuesday & every other Saturday Job Details This position is responsible for the following: Maintain a clean and organized work area during and at the end of each shift. Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. Performs all assigned duties according to departmental SOP's and cGMP's. Remains current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department. Completes and remains current with all required cGMP and safety training. Performs maintenance and repairs of production / packaging equipment to support the on-time delivery to customers, with a minimum amount of downtime. Assist with set-up and changeovers of production / packaging equipment. Troubleshoots equipment and coordinate corrective actions to reduce or eliminate defects, rejects, or equipment downtime. Completes all required documentation associated with the repair and maintenance of production and / or packaging equipment. Provides guidance and training to less experienced mechanics to ensure PM's, line set-up and changeovers are performed within established requirements. Qualifications Education and Experience: Minimum requirements for this position are: Education - Two-year Associate's Degree in Industrial Maintenance, Industrial Systems, Instrumentation, Electrical Systems, Electronics or similar field with a minimum of two (2) - three (3) years of experience in industrial maintenance performing mechanical/electrical repairs OR High School diploma or GED equivalent with three (3) - five (5) years of experience in industrial maintenance performing mechanical/electrical repairs. Experience: Technical - Mastery in Electrical & Mechanical Troubleshooting. Proficiency in Maintenance Methods. Proficiency with multiple types of industrial manufacturing equipment. Experience: Regulatory - Experience working in a cGMP or FDA regulated manufacturing environment preferred. Essential Knowledge, Skills & Abilities: Detail-oriented and self-motivated Excellent hand-eye coordination and manual dexterity. Excellent math skills; ability to add, subtract, multiply, and divide. Ability to read, comprehend, write, and communicate effectively in English. Ability to carry out detailed written or oral instructions. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. Basic user knowledge and understanding of Windows-based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Physically able to continuously stand and walk. Physically able to lift up to 40 lbs. for men and 35 lbs. for women. Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently. Knowledge of manual and automated production / packaging equipment. Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment. Ability to apply troubleshooting principles with industrial equipment. Working knowledge of Filling/Packaging equipment. Must be able to work independently and with minimal supervision. Ability to read Electrical and Mechanical manuals and schematics. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $56k-72k yearly est. 22h ago
  • Packaging Operator III, MA Packaging, B1 Shift (7AM-7:30PM)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Perform production line duties required to meet production goals while complying with quality standards and safety requirements. Operate production equipment and complete documentation in accordance with cGMP's and department SOP's while monitoring product to ensure quality standards are maintained. This position is the B1 Shift 7AM-7:30PM Thursday/Friday/Saturday & every other Wednesday Job Details This position is responsible for one or more of the following duties or activities (See individual department areas in this document for specific accountabilities): Maintain a clean and organized work area during and at the end of each shift. Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. Perform all assigned duties according to departmental SOP's and cGMP's. Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department. Complete and remain current with all required cGMP and safety training. Perform tasks in the production / packaging of product to provide on-time delivery to customers. Complete all required documentation associated with the production and / or packaging of product. Assist daily production in operating and monitoring technical, computerized, production machinery, ensuring quality standards are maintained. Perform other duties as assigned Qualifications Minimum requirements for this position are: Education - High School degree or equivalent. Experience: Technical - Previous experience working in a manufacturing setting preferred. Previous experience with high speed production lines and equipment preferred. Experience: Regulatory - Experience working in a GMP regulated environment preferred. Experience: Aseptic - Experience working in an Aseptic Production environment preferred. Essential Knowledge, Skills & Abilities: Detail-oriented and self-motivated Excellent hand-eye coordination and manual dexterity. Excellent math skills; ability to add, subtract, multiply, and divide. Ability to read, comprehend, write, and communicate effectively in English. Ability to carry out detailed written or oral instructions. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Ability to work any shift (up to 12-hours) as required dependent on business needs. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $31k-36k yearly est. 23d ago
  • Manufacturing Tech I, MD Fill, B2 6PM-6:30AM

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Perform production line duties required to meet production goals while complying with quality standards and safety requirements. Operate production equipment and complete documentation in accordance with cGMP's and department SOP's while monitoring product to ensure quality standards are maintained. This is for the B2 Shift 6PM-6:30AM Wednesday, Thursday, Friday & every other Saturday This position is responsible for one or more of the following duties or activities: Maintain a clean and organized work area during and at the end of each shift. Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. Perform all assigned duties according to departmental SOP's and cGMP's. Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department. Complete and remain current with all required cGMP and safety training. Perform tasks in the production / packaging of product to provide on-time delivery to customers. Assist Maintenance Technicians with basic mechanical adjustments as needed. Perform set-up and changeovers on production / packaging equipment. Troubleshoot equipment and coordinate corrective actions to reduce or eliminate defects, rejects, or equipment downtime. Complete all required documentation associated with the production and / or packaging of product. Assist daily production in operating and monitoring technical computerized, production machinery ensuring quality standards are maintained. Perform other duties as assigned. Qualifications High School diploma (or equivalent experience), with 2+ years experience. Associates degree in science, with 1+ years relevant experience. Bachelor's Degree with 0+ year relevant experience preferred. Detail-oriented and self-motivated Excellent hand-eye coordination and manual dexterity. Excellent math skills; ability to add, subtract, multiply, and divide. Ability to read, comprehend, write, and communicate effectively in English. Ability to carry out detailed written or oral instructions. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Ability to work any shift (up to 12-hours) as required dependent on business needs. Physically able to continuously stand and walk. Physically able to lift up to 40 lbs. Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently. Effective and efficient operation of manual and automated production equipment. Provide guidance and training as required. Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $42k-52k yearly est. 22h ago
  • Manufacturing Supervisor II, MD Fill- A1 Shift 6AM-6:30PM

    Abbvie, Inc. 4.7company rating

    Abbvie, Inc. job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The role of the Manufacturing Supervisor II has knowledge and experience in its field while still building expertise. Is expected to work autonomously with little or no direct supervision. Lead and facilitate safe operations in line with all safety, regulatory and operational requirements. Assure the long-term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. * This is an A1 Shift role: 6AM-6:30PM Sunday/Monday/Tuesday & every other Wednesday Responsibilities * Safety: Create an environment where safety is the number one priority in every activity that you do, driving safety improvements and conducting safety gembas routinely. Be present on the floor promoting a culture of zero safety incidents in compliance with all EHS requirements. * People: Responsible for daily effective deployment of team members and ensure tasks are appropriately delegated to meet the production schedule. Ensure that team members are trained to the required standards of their job. Drives engagement with team by having regular 1:1s, conducts performance reviews and has survey actions plans in place. Ensure time and attendance is approved on time each week so that employees are paid correctly. Communicating effectively with team cascading important info. * Operational: Provides assistance in developing weekly goals and production schedules to determine unit assignments and critical actions with little or no supervision. Responsible for the effective coordination of the activities within the shift to meet the production schedule. Ensure a smooth shift handover with the next manager to ensure departmental activities are planned and executed safely. * Compliance: Ensure compliance with applicable regulatory agencies. Implement a proactive compliance management process where material checks, line clearance checks and spot checks are conducted routinely. Effectively manage any compliance issue that arises during shift that could potentially impact on lot completion. * Performance: Responsible for change-over time management and complete cycle time management. Continuously seeks to identify improvements and supports the implementation of process improvement projects. Responsible for managing resources across all of production to maximize shift throughput. Accountable for overall shift training program (where applicable).Knows all metrics and actively supports initiatives to ensure their area meets expectations and targets. * Development: Be proactive in self-development by having a growth mindset towards personal development. Ensures all employees in their organization have development action/ plans in place and arranging opportunities for growth. * Operation Excellence (OpEx): Participates in process improvement initiatives. Qualifications Qualifications * Bachelor's degree is required. A degree in sciences or engineering is preferred. A minimum 2 years experience supervising or leading a functional team. Experience in regulated pharmaceutical industry is strongly preferred. * Experience: Systems - Proficient in Microsoft Office and other manufacturing systems, such as SAP. Familiarity with industrial automation (distributed control and PLC based systems). Experience in cross functional process improvement initiatives is preferred. * Experience: Regulatory- Working knowledge of safety, quality systems, and cGMPs is required. * Experience: Aseptic (If applicable) -Experience working in an aseptic production environment preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $110k-133k yearly est. 22d ago
  • Senior Engineer, Onsite, Waco, TX (Onsite)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description An engineering professional who, working with little or no supervision, applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline. A Senior Engineer has general knowledge of other related disciplines beyond their own area of expertise. Responsibilities: Responsibilities of this engineering grade level inherently include and expand upon the responsibilities established for lower engineering grade levels. Collaborates with multiple departments to assess and develop corrective and preventative actions (CAPA) for non-conformance reports (NCR) related to issues with process or product when procedures or policy requirements are not met. Responsible for compliance with applicable policies and procedures. Independently plans and conducts investigations . Manages multiple, often concurrent, investigations and meets deadlines. Responsible for achieving investigation completion targets in support of business objectives. Balances multiple demands. Represents Technical Operations Investigations on root cause analysis (RCA) task forces. Identifies full range of customer/client needs and proposes solutions to address them. Qualifications Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 5+ years of significant engineering and/or operational experience. Has demonstrated competency within a discipline. Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Demonstrates judgment within defined procedures and practices to determine appropriate action. Interacts well with diverse groups within manufacturing operations and QA and maintains strong working relationships with internal and external collaborators. Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations. Works well with other colleagues in a collaborative, fast-paced goal-driven environment. Possesses interpersonal skills to negotiate and reconcile differences. Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred). Has demonstrated competency with financial systems and in fiscal control. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $103k-128k yearly est. 23d ago
  • QC Lab Supervisor I (Tuesday-Saturday 2pm-10pm)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description The QC Lab Supervisor I is responsible for the organization, administration, and supervision of Lab Analysts and other Lab employees; properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. Oversees the processes of the chemical analysis and release of raw materials, in-process, and final products in compliance with current quality criteria while respecting deadlines and managing costs. Ensures effective and efficient utilization of laboratory resources through management of laboratory support activities. Responsible for leading and developing a high performing team while prioritizing shop floor presence. This includes hiring, setting performance expectations, providing continuous and on-time performance feedback, coaching staff, assisting in problem-solving, and handling employee matters. Ensures that the department has the appropriate talent and level of performance to meet business objectives. Monitors administration of training, identifies training needs, and ensures development of team. Oversees the operation and functions of the laboratory group which may include Raw Materials, Finished Products, Projects/validation samples, MEC, and stability samples. Organizes laboratory activity by coordinating the activity of personnel depending on the demands of planning. Controls the products (raw materials, intermediates, and finished products) by following procedures (general, specific, of analysis and use, and qualification of equipment) to meet the lab testing schedule. Oversees s Identifies aspects of the tests or results warranting further attention and implements corrective actions. Reviews and approves Analytical data (may relate to analytical product release depending on regional regulatory requirements). Supports laboratory investigations, including out-of-specification test results, and ensures effective corrective actions are implemented. Effectively understands, communicates, and presents QC Metrics. Attends and leads Tier meetings. Ensures appropriate procedures are in place and that QC activities are executed in line with internal procedures, requirements of cGMP, and relevant safety standards. Assists in implementing continuous improvement actions to lab processes. Assists analysts with analytical/microbial instrumentation. Assures instrumentation availability to achieve schedule and improves capacity by ensuring that preventive and repair maintenance as well as material qualifications are carried out in a timely matter. Plans the needs of instruments by maintaining permanent technical and technological intelligence. Applies systematic corrections and/or corrective actions that mitigate the risk of recurrent instrumentation failures. Assists in the periodic inspection of laboratory facilities to ensure that they are operated and administered according to Good Manufacturing Practices (GMP) and Good Laboratory Practices, maintaining laboratory audit readiness. When required, support supplier, internal, and regulatory audits May serve as a backup when the Lab Manager is unavailable. Qualifications Bachelor's Degree required, preferably in a Scientific field (Chemistry, Microbiology, or Biology) 2+ years of QC Lab experience required. Demonstrated thorough scientific knowledge and technical expertise in chemistry, technical writing, investigations, analytical laboratory equipment, and laboratory operations required. General knowledge in cGMPs, compendia, and regulations required Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required. Ability to foster an inclusive environment. Ability to work cross-functionally and coordinate work both within the department and with other departments. Ability to interpret the impact of laboratory data for appropriate and effective actions. Ability to identify, develop, communicate, and follow through to completion necessary corrective action plans to resolve problems. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $111k-137k yearly est. 22h ago
  • Aseptic Site Trainer

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description The Aseptic Site Trainer is responsible for assisting in the coordination of delivery of high-quality educational services and solutions. Aseptic Site Trainer provides administrative support in the implementation of training programs and in the ongoing facilitation and tracking of training initiatives and requirements. This position involves close collaboration with leaders and associates throughout the organization to ensure that educational solutions are accurate, comprehensive, and applicable to the needs of the business. Responsibilities: Ensure AbbVie Training Policy, process and procedures and regulatory training requirements are implemented at the site. Train new and existing employees on appropriate cleanroom behavior and best practices including but not limited to activities such as equipment intervention and sampling. Supports implementation of global Aseptic Best Practices related to aseptic processes and training Create content and administer periodic refresher training for employees working in the cleanroom areas Create and revise procedures, as needed, related to job function Identify areas of improvement with current aseptic processes at the site and manage continued improvement projects, as needed. Observe employees aseptic gowning technique and provide coaching. Additional aseptic related projects, as assigned by department management Maintain a working knowledge of operations processes. Actively recommend, support, and facilitate continuous improvement projects to increase the effectiveness of training system. Generate various training status tracking reports, present reports to site management. Gowning Training (initial and recertification) Partner with Microbiology and Operations for Environmental Monitoring and Sanitization Training Monthly shift touchpoints focused on a pre-established rolling Aseptic refresher (target 15-20 min 10 topics, conducted when semi-annual refresher training is not performed) Monthly Gemba walks with Aseptic MQA / site leadership 20% of time dedicated to Aseptic Auditing Work with global Aseptic Trainers to develop, then deliver targeted aseptic trainings based on site needs This position will support the entire site for aseptic training. It will be working with the global staff to identify and help roll out additional training if required. Gemba walks and on the floor training reinforcement. Qualifications Bachelor's degree required. Degree program or professional certification in Education, Communication, Training, or a related field is beneficial. Knowledge of regulations and standards for Aseptic manufacturing and application to training. At least 3 years of Aseptic Operations/Quality/Training, combined experience is required. Essential experience should include knowledge of GMPs, aseptic manufacturing, and training processes. Strong oral and excellent written communication skills; excellent organizational skills Strong computer skills necessary, including Microsoft Windows and Office applications Ability to independently manage multiple tasks/assignments, meet deadlines and act with flexibility and initiative to thrive in a dynamic environment of rapidly changing needs. Ability to effectively interact and develop constructive and cooperative relationships with subject matter experts and other business partners Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $64,000 - $122,000 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $64k-122k yearly 22h ago
  • Site Compliance Manager

    Abbvie, Inc. 4.7company rating

    Abbvie, Inc. job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Purpose Manages Quality Engineers and Quality Trainer engaged in activities to support Product Surveillance for Medical Devices and Combination products. The Global Compliance Manager is responsible for the management and coordination of a team of Quality Engineers and Quality Trainer. Manages project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to: Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site's internal audits. Oversees internal, supplier and regulatory audits and preparation activities. Responsibilities * Responsible for Quality System and Compliance investigations and support for processing of complaint/adverse event files following global complaint handling regulations, device tracking, clinical protocol data intake and internal procedures. Ability to analyze current processes and information obtained and make decisions for reportability under 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance regulations. * Conduct, review and approve CAPA and Non-Conformance investigations. Monitor and support Quality Engineers approving investigations. Responsible for CAPA and Non-Conformance program for Global Product Surveillance. * Oversees development of departmental metrics for AbbVie's local and segment management reviews and ad hoc requests. * Oversees supplier quality compliance to support complaint handling in accordance with AbbVie policies. * Assess opportunities for interdepartmental and site harmonization of practices and interruption of quality system requirements. * Review and Approve documents pertaining to department Quality Systems (SOPs, DOPs, forms, etc.). * Provide generalized Quality System, company, departmental and product knowledge as required. * Collect data and analyze as required to support inquiries from Regulatory bodies, internal and external customers. * Monitor department processes and workflow compliance to regulatory and department procedures and policies and for opportunities for improvement and optimization. * Responsible for Regulatory audit preparation and execution. Host audits on site and travel to other sites to support audits and inspections as needed. Maintain internal audits schedule and organize audits to self-identify compliance non-conformities. Provide leadership and design for back room audit support activities and document reviews. Qualifications * Bachelor's degree (scientific degree preferred) and seven to eight years related experience and/or training in a regulated industry (Pharmaceutical, Medical Device, Nuclear, etc..) or in a medical environment. Supervisory experienced preferred but not required. * Knowledge of applicable regulations including, but not limited to, 21 CFR 803, 21 CFR 820, 21 CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and other international complaint handling and vigilance regulations. * Experience in TrackWise and eLMS preferred. * Ability to communicate and collaborate with other departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, and Marketing departments to ensure corporate goals and strategies are met. * Ability to initiate or suggest plans to motivate workers to achieve work goals. * Ability to provide accurate and complete information in a prompt manner. * Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities. * Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $99k-124k yearly est. 22d ago
  • Equipment Technician IV, Tuesday- Saturday (6PM-2:30AM)

    Abbvie 4.7company rating

    Abbvie job in Waco, TX

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Perform Maintenance duties required to support production goals while complying with quality standards and safety requirements. Diagnose production and / or packaging equipment to determine repair needs. Perform repairs in a timely manner and complete all required documentation in accordance with cGMP's and department SOP's. Maintain equipment functionality through the preventative maintenance program. Job Details This position is responsible for the following: Maintain a clean and organized work area during and at the end of each shift. Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. Performs all assigned duties according to departmental SOP's and cGMP's. Remains current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department. Completes and remains current with all required cGMP and safety training. Performs maintenance and repairs of production / packaging equipment to support the on-time delivery to customers, with a minimum amount of downtime. Assist with set-up and changeovers of production / packaging equipment. Troubleshoots equipment and coordinate corrective actions to reduce or eliminate defects, rejects, or equipment downtime. Completes all required documentation associated with the repair and maintenance of production and / or packaging equipment. Provides guidance and training to less experienced mechanics to ensure PM's, line set-up and changeovers are performed within established requirements. Qualifications Minimum requirements for this position are: Education - Two-year Associate's Degree in Industrial Maintenance, Industrial Systems, Instrumentation, Electrical Systems, Electronics or similar field with a minimum of two (2) - three (3) years of experience in industrial maintenance performing mechanical/electrical repairs OR High School diploma or GED equivalent with three (3) - five (5) years of experience in industrial maintenance performing mechanical/electrical repairs. Experience: Technical - Mastery in Electrical & Mechanical Troubleshooting. Proficiency in Maintenance Methods. Proficiency with multiple types of industrial manufacturing equipment. Experience: Regulatory - Experience working in a cGMP or FDA regulated manufacturing environment preferred. Essential Knowledge, Skills & Abilities: Detail-oriented and self-motivated Excellent hand-eye coordination and manual dexterity. Excellent math skills; ability to add, subtract, multiply, and divide. Ability to read, comprehend, write, and communicate effectively in English. Ability to carry out detailed written or oral instructions. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment. Basic user knowledge and understanding of Windows-based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Physically able to continuously stand and walk. Physically able to lift up to 40 lbs. for men and 35 lbs. for women. Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently. Knowledge of manual and automated production / packaging equipment. Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment. Ability to apply troubleshooting principles with industrial equipment. Working knowledge of Filling/Packaging equipment. Must be able to work independently and with minimal supervision. Ability to read Electrical and Mechanical manuals and schematics. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $56k-72k yearly est. 31d ago

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