Manufacturing Process Specialist
6 giorni fa
We are seeking individuals who are committed to enhancing the quality of life for people globally.
Process Engineer will contribute to our mission of prioritizing safety and maintaining the highest standards of quality in pharmaceutical manufacturing, bringing enthusiasm, technical knowledge, and a full commitment to their role.
Organizational Overview:
The Production Organization at our facility consists of two parenteral departments – Insulin module and PFS (Prefilled Syringes) module – along with a Packaging & Device Module and the Utilities department.
The strategic structure of the site is designed around cross-functional teams at various levels to ensure robust performance and reliability of production equipment, aiming for operational excellence.
The Process Engineer is a key member of the Process Team, which includes representatives from engineering, technical service, quality, operations, and process automation. This role serves as the primary contact for daily operational issues and escalations related to the assigned systems, encompassing operation, maintenance, and in-process quality control.
Reporting directly to the Engineering Senior Manager of the module, the Process Engineer acts as the technical liaison within the Process Team, addressing all technical aspects concerning the process and equipment from a reliability and maintenance perspective to meet production goals.
Key Responsibilities:
Hold technical accountability and possess in-depth knowledge of the process and its components (including documentation). Ensure optimal system efficiency and adherence to the production schedule by monitoring cycles, equipment data, and area metrics (OEE, alarms, stoppages, etc.). Develop, integrate, and review Standard Operating Procedures (SOPs) and Technical Assessments for the assigned systems to ensure operational standardization and knowledge transfer across the team. Investigate production issues that may impact quality or safety (deviations). Manage troubleshooting and resolution of complex issues while providing technical coaching on problem-solving. Collaborate with the Maintenance Team to ensure timely execution of preventive and corrective actions, maintaining safety and quality standards. Plan and oversee shutdown or production stoppage activities in coordination with the Maintenance Manager, ensuring effective execution during these periods. Propose and lead continuous improvement initiatives related to maintenance policies, equipment reliability, communication processes, data analysis, and safety practices. Analyze relevant Key Performance Indicators (KPIs) such as OEE, maintenance work order execution, HSE, quality, and data integrity to assess improvement projects. Identify and address anomalies within the systems, collaborating with the team to resolve issues and prevent recurrence. Work alongside the Technical Team and Responsible Engineer to execute tests and modification protocols. Engage with internal stakeholders to understand their requirements and develop appropriate action plans. Interface with external contractors as necessary to involve them in projects.Basic Qualifications:
Master’s Degree in Engineering (Mechanical, Chemical). Strong focus on HSE, quality, and data integrity. Proficiency in English (minimum B2 level). A minimum of 1-2 years of experience in engineering, maintenance, or a related technical role, preferably within the pharmaceutical industry.Preferred Skills:
Teamwork and problem-solving orientation. Ability to work effectively under pressure. Multitasking capabilities. Proficiency in Microsoft Office. Knowledge of data analytics and basic statistical methods. Understanding of maintenance fundamentals and metrics. Familiarity with safety regulations related to machinery (Machinery Directive, PED, etc.).Lilly is committed to diversity and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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