Sr. Manufacturing Systems Engineer
Company | Legend Biotech |
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Location | Somerset County, NJ, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree in Computer Science, Information Technology, Information Systems, Engineering, or related field.
- 7+ years experience working with Manufacturing Execution Systems (MES) in a Pharmaceutical or Biotech GxP manufacturing environment.
- Proven experience implementing or supporting MES systems while meeting Quality and Compliance requirements.
- Demonstrated experience with Computer Systems Validation, Qualification activities, and change controls related to implementation and system changes in a GxP environment.
- Strong understanding and experience working in a Cell Therapy manufacturing environment.
- Proficient experience working with regulatory requirements, including GxP, SOX, and data privacy.
- Outstanding organizational skills with demonstrated ability to prioritize workload and attention to detail.
- Excellent written and presentation skills with the proven ability to communicate with all levels including management and external partners.
- Exceptional interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence
- Demonstrated success collaborating in cross-functional teams.
- Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.
Responsibilities
- Lead, deliver, and support of global Manufacturing (MES) solutions, ensuring alignment with cross-functional business and technical teams.
- Define MES standards in alignment with the global IT and Manufacturing strategies.
- Partner with global and local site team Business and Technical Owners to ensure alignment and consistency of a global MES solution.
- Develop and optimize system integrations between MES and other Legend Biotech systems, including automation systems.
- Collaborate with Business Process Owners to manage and prioritize demand intake, including support and enhancement requests.
- Facilitate continuous improvement and feedback opportunities for MES internally with stakeholders and externally with MES vendors.
- Lead lifecycle management of MES projects, supporting timelines, testing, and quality requirements to maintain a robust MES landscape.
- Communicate MES solution strategies to raise support and alignment from the business.
- Assess impact to MES and upstream/downstream systems for any changes and/or downtime windows.
Preferred Qualifications
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No preferred qualifications provided.