Job Title: MES Specialist (TULIP Interfaces)
Job Summary: We are seeking an experienced MES Specialist with a strong background in pharmaceutical manufacturing execution systems (MES), specifically focusing on TULIP interfaces. The ideal candidate will have over 5 years of experience in recipe design, validation processes, and troubleshooting MES integrations. This role is crucial for ensuring compliance and efficiency in our manufacturing operations.
Key Responsibilities:
- Recipe Design and Authoring:
- Develop and author recipes for pharmaceutical products, including biologics, solid and liquid dosages, and packaging processes.
- TULIP Validation:
- Lead the validation of TULIP interfaces by authoring and executing validation documents. Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing to ensure system reliability and compliance.
- Documentation:
- Create and maintain comprehensive validation documentation, including protocols, reports, and change controls, ensuring alignment with regulatory requirements.
- Troubleshooting and Support:
- Provide expert troubleshooting for MES machine integrations, with a focus on resolving issues related to lab equipment integration. Work collaboratively with cross-functional teams to identify and implement solutions.
- Collaboration:
- Work closely with engineering, quality assurance, and production teams to ensure seamless integration and execution of MES solutions.
- Continuous Improvement:
- Identify opportunities for process improvements within the MES framework and contribute to the enhancement of overall system performance.
Preferred Qualifications:
- Experience with lab execution systems and their integration with MES.
- Knowledge of regulatory requirements within the pharmaceutical industry.
- Familiarity with industry best practices for MES implementation and validation.
Required Skills:
- Strong understanding of pharmaceutical manufacturing processes and regulatory guidelines.
- Excellent analytical and problem-solving skills.
- Proficiency in TULIP software and related MES tools.
- Strong communication skills, both written and verbal, with the ability to work effectively in a team environment.
Education:
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field. Advanced degree preferred.
Experience:
- Minimum of 5 years in pharmaceutical MES, with a focus on TULIP interfaces and validation processes.