Manufacturing Process Engineer
- Monza
- Tempo indeterminato
- Full time
- Attend all technology transfer phases from initial project kick-off to process implementation as a technical operations Expert.
- Act as the Single Use Systems (SUS) domain guide, driving the design, selection, and implementation of disposable technologies for aseptic manufacturing of injectable drugs.
- Lead collaborations with vendors and suppliers to craft innovative SUS solutions, ensuring technical excellence, cost-effectiveness, and regulatory compliance.
- Review and propose innovative SUS technologies to enhance process robustness, sterility assurance, and operational flexibility. Stay ahead of industry advancements and emerging solutions in disposable technologies.
- Work closely with clients and internal collaborators to propose and suggest personalized solutions, incorporating client-specific needs and aligning with regulatory and operational standards.
- Develop and optimize process flow diagrams that incorporate SUS technologies, identifying process gaps and recommending technical solutions to ensure flawless integration with existing or new facilities.
- Drive the preparation and review of User Requirements Specifications (URS) and other key documentations, ensuring transparency and alignment with client and regulatory requirements.
- Lead technical protocols and reports for the trials of new products. Ensure that related activities are performed accurately on the shop floor. Provide support for potential quality investigations and mitigation actions definition and implementation.
- Provide technical guidance and support for technical trials and engineering trials, ensuring all activities meet the highest standards of sterility, safety, and compliance.
- Analyze data with statistical tools to better understand the processes.
- Resolve complex process and equipment issues, collaborating with multi-functional teams including production, maintenance, engineering, and quality assurance.
- Develop and deliver technical training and knowledge-sharing sessions for internal teams and clients on process related topic and SUS systems.
- Promote and ensure compliance with regulatory standards (FDA, EMA, AIFA, etc.). Drive innovations by managing Change Controls and improvements from CAPAs.
- MS or equivalent experience in Chemical Engineering, Industrial Engineering, CTF, Biotechnology, or related fields.
- Experience with manufacturing processes and equipment in related fields: Pharma Fill & Finish, Pharma Upstream & Downstream, API, Chemical, Food.
- Experience with liquid and lyophilized sterile injectable drugs is a plus.
- Knowledge and understanding of cGMP.
- Curious mentality.
- Proactivity and ability to achieve goals despite challenges.
- Good communication and interpersonal skills and ability to work in multi-disciplinary teams.
- Very good level of English (spoken and written) and Italian.