Lead Mes Engineer

We are seeking a highly skilled and experienced Lead MES Engineer to join our dynamic team and support projects in the pharmaceutical industry. As the Lead MES Engineer, you will play a critical role in the successful implementation and integration of Manufacturing Execution Systems (MES) within our client's pharmaceutical manufacturing facilities. You will work closely with cross-functional teams, including project managers, automation engineers, quality assurance, and operations personnel to ensure efficient and compliant MES solutions.

**Responsibilities**:

- Lead MES Implementation: Take ownership of MES implementation projects, overseeing the entire lifecycle from design and development to testing, deployment, and validation. Collaborate with stakeholders to define project goals, objectives, scope, and deliverables.
- Technical Expertise: Provide expert-level knowledge and guidance on MES platforms, including selection, configuration, and customization. Stay updated on the latest trends and advancements in MES technology and assess their applicability to project requirements.
- System Integration: Collaborate with cross-functional teams to integrate MES with existing manufacturing systems (e.g., ERP, LIMS) and equipment (e.g., PLC, SCADA) to ensure seamless data flow and process control. Troubleshoot and resolve any integration issues that may arise.
- Compliance and Validation: Ensure that MES implementations adhere to regulatory requirements (e.g., FDA, GMP) and industry best practices. Develop and execute validation strategies, including the creation of validation protocols, test scripts, and documentation.
- Team Leadership: Provide technical leadership and mentorship to a team of engineers involved in MES projects. Assign tasks, set expectations, and monitor progress to ensure timely and high-quality project deliverables.
- Risk Assessment and Mitigation: Identify potential risks and develop strategies to mitigate them throughout the project lifecycle. Proactively communicate and escalate any risks or issues to project stakeholders.
- User Training and Support: Develop and deliver training programs to end-users on MES functionalities and usage. Provide ongoing technical support to resolve any system-related issues or user inquiries.
- Continuous Improvement: Drive continuous improvement initiatives to optimize MES performance, reliability, and usability. Collaborate with stakeholders to identify opportunities for process automation, data analytics, and system enhancements.

**Qualifications**:

- Bachelor's degree in Engineering, Computer Science, or a related field. A master's degree is preferred.
- Minimum of 8 years of experience in implementing and supporting MES solutions in the pharmaceutical or biotech industry.
- In-depth knowledge of MES platforms such as Werum PAS-X, Rockwell ProPack Data, or Siemens SIMATIC IT, and their integration with other systems.
- Strong understanding of pharmaceutical manufacturing processes, regulatory requirements (FDA, GMP), and quality systems (e.g., GAMP 5).
- Proficient in programming languages (e.g., C#, SQL) and industrial automation protocols (e.g., OPC, Modbus).
- Experience in leading cross-functional project teams and managing multiple projects simultaneously.
- Excellent problem-solving and analytical skills with the ability to navigate complex technical challenges.
- Strong communication skills to effectively collaborate with stakeholders at various levels within the organization.
- Familiarity with Lean Manufacturing, Six Sigma, or other process improvement methodologies is a plus.
- Join our team as a Lead MES Engineer and contribute to the successful implementation of MES solutions in the dynamic pharmaceutical industry. This role offers exciting challenges, career growth opportunities, and the chance to make a significant impact on improving manufacturing operations and patient safety.