Sterile Filling Engineer

*Job Title:* Sterile Filling Engineer*Location:* Raleigh, NC*Job Type:* Long Term Contract*Position Summary:*Our client is seeking a highly skilled and motivated Sterile Filling Engineer to join our pharmaceutical manufacturing facility in Raleigh, NC. The Sterile Filling Engineer will be responsible for supporting the start-up and daily production of the site's new Sterile Pre-Filled Syringe line. This role requires expertise in the areas of process and equipment qualification, improving manufacturing and business processes, process safety management, and adherence to business systems. The Sterile Filling Engineer will take ownership of process equipment, ensuring proper maintenance practices to maximize equipment performance and longevity.*Key Responsibilities:**Process and Equipment Qualification:** Ensure equipment is commissioned and qualified to meet all safety, compliance, and operational objectives.* Primary process owner at the unit operations level, integrating process and equipment knowledge.* Lead or participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new equipment or areas.* Provide technical leadership and support for equipment installation, commissioning, and qualification.*Filling Process Operations:** Monitor established control systems for process indicators, identifying and following up on significant issues.* Troubleshoot filling processes and equipment, resolving issues leading to production delays using formal problem-solving techniques (including root cause analysis).* Perform periodic reviews and maintain the qualified state of supported systems.* Own equipment-related deviation investigations, corrective/preventive actions, and changes.* Support the transfer of knowledge regarding equipment capabilities and operational techniques to operations and maintenance teams.*Process Improvement and Optimization:** Develop and maintain process team project improvement activities focused on yield, cycle time, cleaning, product quality, raw material costs, waste loads, equipment reliability, and process safety.* Perform and summarize improvement opportunities through statistical analysis, plant trials, investigations, and process/unit operations modeling.* Identify better equipment/unit operation technologies to enhance process efficiency.* Analyze and document common causes of incidents, developing proposals to close identified gaps in process and site metrics.*Process Safety Management:** Lead and support Safety and Process Safety incident investigations, providing technical leadership and problem-solving skills.* Perform compliance-related technical tasks such as emissions calculations, equipment evaluation, and material balances for environmental needs.* Lead or participate in process hazard reviews (PHRs) and other process safety activities, serving as the main resource for process safety issues.*Adherence to Business Systems:** Ensure the implementation of countermeasures arising from deviations, spills, and safety-related events.* Manage the implementation of recommendations from PHRs and other audit findings.* Maintain and analyze process team metrics, such as cycle time and changeovers.* Develop and maintain the technical documentation for all processes and equipment.*Qualifications:** *Basic Qualifications:** Bachelor's Degree in Engineering (Chemical, Mechanical, or related field) or a related discipline.* Minimum of 2 years of experience in an engineering, maintenance, or technical support area, preferably in a pharmaceutical, biotechnology, or related industry.* Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.* *Preferred Qualifications:** Strong understanding and experience with sterile filling lines.* Knowledge of pharmaceutical cGMPs (current Good Manufacturing Practices) and their application to work processes.* Experience with automated processes, including Distributed Control Systems (DCS) (e.g., DeltaV, PRoVOX) and/or Programmable Logic Controller (PLC) systems.* Experience with process improvement methodologies, such as Six Sigma or Lean.* Expertise in root cause analysis tools (e.g., Fishbone Diagram, Fault Tree Analysis, Failure Mode and Effects Analysis (FMEA)).* Strong written and oral communication skills, with the ability to communicate effectively across all organizational levels.*Additional Skills/Preferences:** Ability to apply fundamental engineering principles to process understanding, problem-solving, and process improvement.* Strong computer skills in various software packages (Microsoft Office, Aspen Process Explorer, etc.).* Experience working cross-functionally with Tech Service/Manufacturing Sciences, Automation, Maintenance, Quality Assurance, Quality Control, and other teams.* Experience in leading capital projects or acting as a user representative for capital project initiatives.* Ability to manage and prioritize competing priorities in a dynamic environment.Job Types: Full-time, ContractPay: $60.00 - $70.00 per hourExpected hours: 40 per weekSchedule:* 8 hour shift* Monday to FridayApplication Question(s):* Are you currently local to Raleigh, NC?* Are you open to travel?* Do you have any prior Pharmaceutical Manufacturing experience?Ability to Commute:* Raleigh, NC 27602 (Required)Work Location: In person

Created: 2025-03-04