Senior Quality Engineer - Combo Product External Quality

Join AbbVie as a Senior Quality Engineer focused on Combo Product External Quality. In this pivotal role, you will ensure the quality and compliance of our innovative combo products. Collaborate with cross-functional teams to uphold our commitment to excellence in healthcare solutions. Your expertise will be instrumental in driving quality initiatives and ma…

Join AbbVie as a Senior Data Engineer, where you will play a key role in designing and implementing innovative data solutions that drive our mission. You will collaborate with cross-functional teams to ensure data integrity and availability, leveraging your expertise in data architecture and engineering.

Join AbbVie as a Principal Controls Engineer, where you will play a pivotal role in developing innovative control systems that enhance our operations and product quality. You will collaborate with cross-functional teams to design, implement, and optimize control strategies that drive efficiency and compliance within our manufacturing processes.

Join AbbVie as a Senior Engineer in Process Safety, where you will lead initiatives to enhance safety protocols and ensure compliance with industry standards. Your expertise will drive the development of innovative solutions to manage process safety hazards effectively, contributing to our commitment to excellence in patient safety and product quality.

Join our dynamic team at AbbVie as a Principal Engineer specializing in Quality Assurance and DevOps. In this integral role, you will lead the development and implementation of robust testing frameworks and automation strategies to ensure the highest quality of our software products. Your expertise will guide our engineering practices, enabling us to deliver innovative solutions that meet the evolving needs of our customers.

AbbVie is seeking a visionary Director of Global Engineering Strategy and Planning to lead our engineering initiatives and strategic planning efforts on a global scale. This role is crucial in shaping the future of our engineering practices and ensuring alignment with our organizational goals.

We are seeking a highly skilled and experienced Director of Process Engineering specializing in Peptides to join our innovative team at AbbVie. In this pivotal role, you will lead the process engineering initiatives that drive the development and optimization of peptide manufacturing processes, ensuring quality and efficiency in our operations.

The Senior Electromechanical Device Engineer will play a pivotal role in the comprehensive development of cutting-edge electromechanical devices, particularly focusing on infusion pumps that interface with subcutaneous infusion sets and syringes. This position will spearhead and participate in design verification and validation activities for infusion pump systems. As a subject matter expert (SME), you will serve as a technical liaison, ensuring effective communication and collaboration with both internal teams and external partners.Possess a solid understanding of electromechanical devices.Develop and implement design verification plans while authoring verification reports.Conduct thorough root cause analyses to address issues associated with electromechanical devices and their interfaces with disposables.Assist in the formulation of system, subsystem, and interface design requirements.Support the creation and upkeep of traceability between design inputs, outputs, verifications, and validations. Aid in identifying and implementing product and process enhancements, managing the infusion pump system interface traceability matrix.Ensure the quality and efficacy of project outcomes through effective process design and improvements, early risk assessments, regular testing, and engineering analyses.Exhibit strong verbal, written, and interpersonal communication skills, with the capability to engage at all organizational levels.Participate in design reviews, providing valuable feedback on mechanical designs.Guarantee compliance with medical device industry standards and regulations.Collaborate with internal and external stakeholders in the industrialization of consumables within manufacturing.

Join AbbVie, a global biopharmaceutical company, as a Systems Engineer where innovation meets healthcare. In this role, you will contribute to developing and maintaining complex systems that support our commitment to improving lives through advanced medical solutions.

Join AbbVie as a Reliability Engineering Technician focused on Predictive Maintenance (PdM). This is an exciting opportunity for recent graduates or those looking to start their career in engineering. You will play a vital role in ensuring the reliability and functionality of our systems while collaborating with seasoned professionals in a dynamic environment.

Join AbbVie as a Senior Scientist II in Automation Engineering, where you will drive innovation and technical excellence in our automation processes. In this role, you will leverage your expertise to develop and implement automated solutions that enhance our research and development operations. Collaborate with cross-functional teams and contribute to cutting-edge projects that ultimately improve patient outcomes.

Join AbbVie as an Executive Protection Specialist, where you will play a pivotal role in safeguarding our top executives. You will be responsible for assessing risks, implementing protective measures, and ensuring a safe environment during travel and public appearances.

Join AbbVie as a Scientist II in our Engineering department, specializing in Oral Solid Dosage forms. This role involves the application of engineering principles to develop and optimize pharmaceutical products. You will collaborate with cross-functional teams to ensure the successful progression of projects from concept to commercialization while adhering to regulatory standards.

Join AbbVie as a Senior Principal Research Scientist in Engineering, where you will lead groundbreaking research initiatives and contribute to the development of innovative solutions that enhance patient care. You will be part of a dynamic team dedicated to pushing the boundaries of science and technology.

Join AbbVie as a Principal Research Scientist I in Process Engineering, where you will play a pivotal role in advancing our innovative therapeutic solutions. Collaborate with a dynamic team to drive process development and optimization, ensuring the highest quality in our products.

Join AbbVie as a Global Process Engineer (Aseptic). In this pivotal role, you will leverage your expertise in aseptic processing to enhance our global manufacturing capabilities, ensuring that our pharmaceutical products meet the highest quality standards.

As a Senior Quality Engineer, you will play a crucial role in representing the Quality Assurance (QA) function on interdisciplinary teams focused on the development of combination products and medical devices. Your primary responsibility will be to ensure that all aspects of product development, manufacturing, testing, and procurement, as well as the resulting data, comply with global Combination Product and Medical Device Regulations.Key Responsibilities:Execute QA activities associated with Combination Product and Medical Device Development to uphold compliance with corporate policies and procedures.Conduct design control and risk management activities in alignment with AbbVie's Quality System.Collaborate with Quality and Operations teams to guarantee adherence to design control documentation and design change control requirements.Manage third-party supplier activities by reviewing their design control processes.Assist in the preparation of regulatory submission documents.Identify and address gaps or opportunities for improvement within the Design History File and Risk Management documentation.Proactively lead projects and process improvement initiatives, anticipating and resolving quality issues.Monitor process effectiveness and quality of project outputs, proposing and implementing improvements.Utilize your knowledge of global regulations and standards to guide compliance efforts.Lead and participate in regulatory agency audits and internal audits.Conduct thorough investigations for Incident Reports (IRRs), Non-Conformance Reports (NCRs), and other observations, ensuring accurate documentation.Engage in departmental Change Control activities, performing impact assessments on design changes.Review and approve design changes pertinent to late-stage development projects.Support regulatory authority interactions, including Notified Body audits.Draft and revise quality procedures, forms, and documentation as required.Collaborate with cross-functional teams to foster continuous improvement and drive change.

Join AbbVie’s Process Engineering team, a vital segment of our R&D Development Sciences organization, where we specialize in the design and development of scalable manufacturing processes for drug substances and products, including small molecules, peptides, and antibody drug conjugates (ADCs). Our team collaborates closely with the Biologics CMC Development and Aesthetics R&D departments to provide essential engineering support for the efficient scale-up and manufacturing of biologics, toxins, and cosmetic active ingredients (CAIs). We are committed to pioneering innovative engineering technologies and creating valuable intellectual property through chemical processes and technologies that lead to cost-effective commercial manufacturing solutions. Our contributions extend to enhancing the supply chain for pipeline molecules and preparing CMC regulatory submissions.As a Chemical/Bio Engineer in Process Engineering, you will support pipeline projects throughout all development phases. Initially, you will focus on establishing scalable processes, followed by optimizing them in later stages and leading manufacturing campaigns. Your role will also involve collaborating cross-functionally to transfer optimized processes to manufacturing sites, developing control strategies, and preparing regulatory support reports.Role OverviewWe are seeking a passionate and hands-on engineering professional to join our R&D Process Engineering function. The primary objective of this role is to develop robust manufacturing processes and advance innovative technologies grounded in solid engineering principles. You will lead the exploration and development of novel approaches to enhance efficiency and facilitate commercialization. A collaborative mindset is essential as you will work on a diverse range of projects and contribute to cross-functional teams to meet specific project requirements.Key Responsibilities:Develop robust manufacturing processes, supporting assets throughout all development phases.Engage in the development and characterization of new assets.Establish, communicate, and execute comprehensive research plans.Create commercially viable manufacturing processes in the laboratory and demonstrate these processes in the pilot plant.Tackle complex challenges involving reactions, separations, and isolations using your expertise in reaction kinetics, transport phenomena, and mathematical modeling.Lead and document experimental findings to support regulatory filings.

Join AbbVie as a Principal Research Scientist II specializing in Peptide Process Engineering. In this pivotal role, you will be at the forefront of advancing our API projects through all phases of late-stage development and commercialization. Your expertise will ensure that processes are executed safely, effectively addressing scale-up challenges and developing robust API process steps from laboratory to manufacturing environment. Once the processes are commercialized, you will drive continuous improvement initiatives, facilitate technical transfers to manufacturing sites, and troubleshoot technical issues in a commercial setting. Successful performance in this role hinges on your ability to foster effective cross-functional collaboration with quality, regulatory, and on-site manufacturing teams.Purpose:Lead a team of scientists in research and project activities within your area of expertise, providing mentorship and guidance. Independently design, implement, and communicate innovative multi-disciplinary research strategies that align with project objectives. You will oversee the design, implementation, and optimization of peptide synthesis manufacturing processes from development through commercialization.Major Responsibilities:Develop and align discipline strategy with functional goals and key scientific objectives.Create and implement innovative approaches using engineering principles.Utilize your extensive knowledge and experience to navigate complex decision-making scenarios.Collaborate with experts to integrate scientific objectives into the development of new or enhanced products and technologies.Enhance scientific expertise within the function by advising and mentoring peers and junior staff.Ensure quality and effectiveness of major project plans through sound design and risk assessments.Identify and integrate emerging scientific trends into functional objectives to advance technology within the discipline.Leadership Activities:Lead the resolution of compliance quality issues and contribute to documentation.Present project results to internal and external stakeholders.Critically review and provide feedback on presentations by colleagues.Establish criteria for project operations and ensure their successful execution.

Join AbbVie as a Manager II, EEDI, where you will lead and drive initiatives within our Enterprise Engineering and Digital Innovation team. This exciting role requires a strategic thinker who can manage projects and collaborate with cross-functional teams to enhance our organizational processes and technological capabilities. Your expertise will contribute to our mission of improving patient outcomes and advancing healthcare solutions.