Aseptic Process Simulation Expert Consultant

Aseptic Process Simulation Expert Consultant We are seeking an experienced Aseptic Process Simulation (APS) Expert Consultant to lead the design and implementation of APS (Media Fill) programs in compliance with the latest EU GMP Annex 1 requirements. This role is ideal for a professional with extensive experience in sterile pharmaceutical manufacturing and a proven ability to establish robust aseptic processes from the ground up. Responsibilities Lead APS Program Development: Design and implement a comprehensive APS strategy where no existing process currently exists. Ensure Regulatory Compliance: Develop protocols and procedures fully aligned with EU GMP Annex 1 and global standards. Documentation & Risk Management: Create SOPs, risk assessments, acceptance criteria, and sampling plans tailored to site needs. Training & Knowledge Transfer: Build and deliver training programs for site personnel on APS principles and regulatory expectations. Execution Oversight: Plan, coordinate, and monitor initial media fills, troubleshoot issues, and ensure successful outcomes. Continuous Improvement: Analyze APS results, manage deviations, and implement CAPAs to maintain compliance and efficiency. Inspection Readiness: Ensure all documentation and processes are audit‑ready and support regulatory inspections. Cross‑Functional Collaboration: Integrate APS into contamination control and quality management systems. Regulatory Support: Provide expert guidance during inspections and audits related to APS. Industry Awareness: Stay current with best practices and regulatory updates to keep APS programs effective. Qualifications Education: Bachelor’s or Master’s degree in Pharmacy, Microbiology, Biotechnology, or related field. Experience: Minimum 10 years in sterile pharmaceutical manufacturing with hands‑on APS/media fill expertise. Regulatory Knowledge: Deep understanding of EU GMP Annex 1 and global aseptic processing requirements. Technical Skills: Strong knowledge of contamination control, cleanroom operations, and environmental monitoring. Soft Skills: Excellent communication, training, and documentation abilities; ability to work independently and collaboratively. Additional: Experience supporting regulatory inspections is highly desirable. Languages: Fluent in French and English. If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful. Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland. Capgemini Engineering is an EEO and Affi­rence® Action Employer of Females/Minorities/Individuals with Disabilities. Benefits A permanent contract with the leader in innovation and high‑tech engineering consulting. A multi‑stage model with career opportunities through specialization prospects with over 250,000 consultants around the world and a Group revenue of EUR 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D). In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva. 30‑70% remote work in agreement with your line manager and client needs. Trust‑based managerial culture. Team rituals and get‑togethers. Options to order ergonomically proven Equipment (monitor & chair) for your home office premises. Seniority level Mid‑Senior level Employment type Full‑time Job function Consulting, Engineering, and Manufacturing Industries Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research #J-18808-Ljbffr