Senior Process Engineer / SME - Single-Use Systems & Aseptic Manufacturing Industry: Pharmaceutical / Biopharmaceutical Position Type: Permanent Consultant Environment: GMP-regulated aseptic manufacturing About the role We are seeking an experienced Process Engineer / Subject Matter Expert (SME) to provide independent technical review and assessment of supplier-provided designs and engineering solutions for a pharmaceutical client. The consultant will act as a technical second set of eyes, applying process engineering expertise and practical knowledge of single-use assemblies in aseptic manufacturing to assess whether proposed solutions are technically appropriate, fit for purpose, and aligned with the intended manufacturing process. Working alongside the client's internal stakeholders and existing design suppliers, the consultant will critically evaluate technical proposals, identify potential gaps or risks, challenge assumptions, and provide clear recommendations to support sound engineering decisions. This is an independent technical advisory role, focused on reviewing and challenging existing solutions rather than executing design work, managing projects, or performing day-to-day manufacturing operations. Key Responsibilities Independent Technical Review: Review and assess supplier-provided designs, engineering proposals, and process-related solutions for technical suitability and fitness for purpose. Process Engineering Expertise: Apply strong process engineering knowledge to evaluate proposed solutions within a pharmaceutical and aseptic manufacturing context. Single-Use Systems and Assemblies: Assess supplier designs involving single-use assemblies and components, drawing on practical experience with their use in aseptic manufacturing. Supplier Design Assessment: Challenge proposed designs and technical assumptions where necessary, identifying potential weaknesses, omissions, inconsistencies, or areas requiring further clarification. Technical Documentation Review: Interpret and critically assess relevant engineering drawings, process flow diagrams, equipment specifications, and other technical documentation provided by suppliers. Technical Risk Identification: Identify potential process-related risks and design gaps, and provide reasoned recommendations for mitigation or further investigation. Technical Advisory: Communicate findings and recommendations to the client's stakeholders, supporting informed technical decisions and constructive discussions with suppliers. Continuous Improvement: Identify opportunities to improve the robustness, suitability, and efficiency of proposed process-engineering solutions through independent technical assessment. Required Qualifications and Experience Degree in Process Engineering, Chemical Engineering, Biochemical Engineering, Biotechnology, or a related technical discipline, or equivalent relevant experience. Strong process engineering experience within pharmaceutical or biopharmaceutical manufacturing. Practical, hands-on experience with single-use assemblies and systems used in aseptic manufacturing environments. Good understanding of aseptic manufacturing processes and relevant GMP principles. Demonstrated experience reviewing technical designs, engineering proposals, or supplier documentation. Ability to critically assess technical solutions, identify potential gaps or risks, and challenge supplier proposals constructively. Strong analytical skills and sound engineering judgment. Ability to work independently and communicate technical findings and recommendations clearly to engineering and technical stakeholders. Preferred Experience Experience with continuous improvement initiatives in pharmaceutical or biopharmaceutical manufacturing. Exposure to compounding, fluid handling, or fill/finish processes. Familiarity with vial-filling processes and associated single-use assemblies. Experience reviewing supplier-generated engineering documentation and technical specifications. Experience conducting technical assessments or design reviews in a GMP-regulated environment. #J-18808-Ljbffr
Senior Process Engineer / SME – Single-Use Systems & Aseptic Manufacturing in Schaffhausen Arbeitgeber: Adryan
Adryan bietet eine hervorragende Arbeitsumgebung in Basel, wo Teamarbeit und Innovation im Mittelpunkt stehen. Unsere Mitarbeiter profitieren von flexiblen Arbeitszeiten, kontinuierlichen Weiterbildungsmöglichkeiten und einem unterstützenden Arbeitsklima, das persönliches Wachstum fördert. Zudem ermöglicht die Lage in Basel den Zugang zu einem dynamischen Netzwerk in der Pharmaindustrie, was zusätzliche Karrierechancen eröffnet.
