Senior Specialist, Engineer, Manufacturing Compliance

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Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.The Senior Specialist, Engineer, Manufacturing & Compliance authors, owns and leads updates of GMP documents/projects related to Bulk and/or Packaging Operations. You will initiates and owns deviations and participate to or lead investigation tasks as required. Also, you will support the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. You will be asked to support and lead projects with the GMP activities (change control, URS, Protocol, etc…)Skills/Knowledge Required

• BS/MS in Engineering/Technical discipline or equivalent experience.
• 7 years’ experience in pharmaceutical validation, packaging, drug manufacturing process or 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
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
• Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes especially in Oral Solid Dosage form (OSD).
• Well-developed ability to constructively work across functional areas and levels to achieve results.
• 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.
• Fluent in English and in French

Duties and ResponsibilitiesThe Senior Specialist, Engineer, Manufacturing & Compliance’s main activities are completed autonomously for the following tasks and responsibilities:

• Initiate deviations and participate to or lead on the floor investigations. Partner with QA and Boudry Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
• Follow up and implement assigned CAPA’s.
• Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, SOPs, forms and logbooks. Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
• Lead or Support manufacturing projects (new equipment, process change, etc…) by managing the documentation associated with the project (URS, Protocol, Change Control, etc…) e. Lead risk assessments, data integrity risk assessment and risk management within cross functional teams (from draft to approval).
• Maintain all risk assessments up to date
• Perform complaint investigations.
• Manage the defect library and the related training for the site.
• Initiate, own, and follow up change controls related to manufacturing (bulk/packaging). Manage stakeholders involved.
• Ensure distribution and withdrawal of GMP documents in manufacturing area.
• Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
• Participate to or lead projects and initiatives as directed by the manufacturing management (bulk/ packaging) Operations.
• Participate or lead technical aspects for specific projects (SAT, FAT, Technical visit at the supplier or on site) to bring technical expertise.
• Act as quality system and GMP Documentation referee for the manufacturing bulk/packaging Ops Team and as a key representative for QA Ops.
• Support the team in proactively monitoring quality, safety and performance/reporting metrics (OEE, Tier Meeting) and in proposing improvement measures

Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.