Principal Compliance Engineer, Bulk and Packaging Operations

vor 2 Wochen


ValdeTravers District, Schweiz WuXi AppTec Vollzeit
About the Role

At WuXi AppTec, we are seeking an experienced Principal Compliance Engineer to lead the development, implementation, and maintenance of our manufacturing compliance strategies for bulk and packaging operations.

Key Responsibilities
  • Develop, author, and maintain GMP documents related to bulk and packaging operations in accordance with current international regulatory requirements, including 21 CFR part 11, 210, and 211, Annex 11, EU-GMP guidelines, and GAMP.
  • Initiate, own, and lead deviations related to bulk and packaging operations, as well as investigation tasks as required.
  • Serve as a referee for operational teams on GMP systems, documentation, and training, ensuring compliance and adherence to regulatory requirements.
  • Support the Head of Bulk and/or Packaging Operations in monitoring quality and performance metrics.
Requirements
  • BS/MS in Engineering or Technical discipline, or equivalent experience.
  • No less than 8 years' experience in pharmaceutical validation, packaging, or a related field.
  • Sound knowledge of current international regulatory regulations, cGxP requirements, and best practices, including 21 CFR part 11, 210, and 211, Annex 11, EU-GMP guidelines, and GAMP.
  • Experience in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
  • Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
  • Strong verbal and written communication skills.
  • Strong analytical, problem-solving, influential, and deductive skills.
  • Capability to work with short deadlines and simultaneous activities.
  • Excellent organizational and project management skills.
  • Successful experience in direct people management.
  • Fluent in English.
Estimated Salary Range:

$120,000 - $180,000 per annum, depending on qualifications and experience.



  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThe Senior Compliance Engineer for Manufacturing Compliance will be responsible for authoring, owning, and leading updates of GMP documents related to Bulk and/or Packaging Operations. This role will also initiate and own deviations related to Bulk and/or Packaging Operations and lead investigation tasks as required. Additionally, the Senior...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. Job Summary: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview The Senior Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Summary:As a key member of the WuXi AppTec team, we are seeking an experienced Bulk Operations Manager to lead our manufacturing operations and ensure the highest standards of quality and health & safety.Key Responsibilities:Lead the daily management of the Bulk team, including planning, communication, team organization, and control to ensure timely...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Summary">The Senior Engineer, Manufacturing Compliance plays a pivotal role in ensuring the highest standards of quality and compliance in our Bulk and Packaging Operations. This position requires a strong background in pharmaceutical validation, packaging, or related fields, with a deep understanding of current international regulatory regulations, cGxP...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    About the RoleThe Manufacturing Compliance Lead authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations at WuXi AppTec. This includes initiating and owning deviations related to these operations and leading investigation tasks as required.ResponsibilitiesSupport the Head of Bulk and/or Packaging Operations in monitoring...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Role Overview WuXi AppTec seeks a highly experienced Manufacturing Compliance Lead to author, own, and lead updates of GMP documents related to Bulk and/or Packaging Operations. The successful candidate will initiate and own deviations related to Bulk and/or Packaging Operations and lead investigation tasks as required. Key Responsibilities Support...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    OverviewThis position serves as a leadership role responsible for the direct management of individual contributors, supervisors, and/or managers. The role is a safeguard and model for WuXi values and competencies.Job Summary:Lead the bulk operations team to ensure that packaging goods are produced according to supply needs and meet the highest standards of...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health & safety are...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    At WuXi AppTec, we are seeking an exceptional Lead Bulk Operations Manager to join our team.The salary for this role is approximately $120,000 per year, depending on location and experience.This leadership position will be responsible for the daily management of the Bulk team, ensuring delivery of goods according to supply needs and highest quality...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryAs a key member of the WuXi AppTec team, we are seeking a Manufacturing Operations Manager to lead the bulk operations team in ensuring the highest standards of quality and health & safety are met.ResponsibilitiesManage the daily activities of the bulk team, planning communication, team organization, control, and monitoring of defined targets to...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products. This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required and maintaining working...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a world leader in the development of innovative therapies that transform patients' lives. We are seeking a highly skilled Bulk Operations Manufacturing Specialist to join our team.As a Bulk Operations Manufacturing Specialist, you will be responsible for manufacturing products in compliance...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryWuXi AppTec is seeking a highly skilled Associate Specialist QA Operations to join our team. In this role, you will be responsible for ensuring the quality of our products and processes, working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues.Key ResponsibilitiesSupport the design...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company that is committed to transforming patients' lives through science. We are seeking a highly skilled and motivated Bulk Operations Operator to join our team.The Bulk Operations Operator will be responsible for manufacturing products in compliance with GMP/cGMP...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Poste de Technicien Bulk OperationsLe WuXi AppTec recrute un Technicien Bulk Operations pour rejoindre son équipe de production.Fonctions et responsabilitésLe technicien Bulk Operations est chargé de la fabrication des produits (capsules ou comprimés) dans le respect des réglementations BPF/cGMPs, des règles d'hygiène et de sécurité. Il doit se...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    PrésentationLe Technicien Bulk Operations de WuXi AppTec aura pour mission d'assurer les activités de fabrication des produits (capsules ou comprimés) dans le respect de la réglementation BPF/cGMP, des règles d'hygiène et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    OverviewAt WuXi AppTec, we are seeking a highly skilled Associate Specialist QA Operations to join our Quality Assurance team. As a key member of our team, you will play a vital role in ensuring the quality and integrity of our products and processes.This position is responsible for supporting the design of Master Batch Records for bulk or packaged...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview Le Technician Bulk Operations aura pour mission d’assurer les activités de fabrication des produits (capsules ou comprimés), dans le respect de la réglementation BPF / cGMPs, des règles d’hygiène, et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site pharmaceutique. Responsibilities ...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    OverviewWe are seeking a Quality Assurance Specialist to join our team at WuXi AppTec. In this role, you will play a critical part in ensuring the quality and compliance of our products.Job DescriptionThis position is responsible for providing quality assurance support primarily with the review of bulk or packaged commercial drug products, raw material...