MES (Manufacturing Execution System (Engineer)

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading biotechnology company is seeking an MES (Manufacturing Execution System Engineer) to support cell therapy manufacturing at their Philadelphia facility. The ideal candidate will have expertise in Emerson Syncade MES, experience in biotech IT, and a strong understanding of pharmaceutical processes. This role involves engineering tasks, operational support, and collaboration with various business teams to enhance efficiency and ensure compliance with industry standards.

Qualifications

• 2-4 years of experience in biotech/pharma IT or consulting.
• At least 1 year of Recipe Authoring experience in Emerson Syncade MES.
• Knowledge of 21 CFR Part 11, Annex 11, cGMP, GAMP5.

Responsibilities

• Perform engineering tasks related to MES, including Recipe Authoring and Equipment Tracking configuration.
• Assist with operational activities such as end-user support and break-fix for MES systems.
• Support major MES projects like EBR authoring and deployment.

Skills

Recipe Authoring

Data Mining

Problem-Solving

Communication

Teamwork

Education

Bachelor's degree in Computer Science, Engineering, or related field

Tools

Emerson Syncade MES

ERP

LIMS

CMMS

Job description

MES (Manufacturing Execution System Engineer)

Join to apply for the MES (Manufacturing Execution System Engineer) role at Iovance Biotherapeutics, Inc.

This position reports to the Manager, IT Manufacturing Systems. The MES Engineer will utilize expertise in Syncade MES Recipe Authoring to develop and maintain Electronic Batch Records supporting cell therapy manufacturing.

The MES Engineer will serve as a technical resource, providing operational support, performing configuration and documentation updates, and maintaining the Syncade MES. The role partners with Manufacturing, Quality, MSAT, and R&D to ensure systems meet business needs.

Essential Functions and Responsibilities

• Perform engineering tasks related to MES, including Recipe Authoring, Equipment Tracking configuration, report configuration, data mining, etc.
• Assist with operational activities such as end-user support and break-fix for MES systems.
• Support major MES projects like EBR authoring and deployment.
• Understand pharmaceutical business processes, data integrity, infrastructure, and architecture.
• Collaborate with business teams to improve processes, efficiency, and reduce costs.
• Adhere to company policies, core values, and ethics.

Travel

• Less than 10% travel required.
• On-site at Philadelphia manufacturing facility >80% of the time.

Required Education, Skills, and Knowledge

• 2-4 years of experience in biotech/pharma IT or consulting.
• At least 1 year of Recipe Authoring experience in Emerson Syncade MES.
• Bachelor's degree in Computer Science, Engineering, or related field.
• Experience in pharmaceutical or medical device industries.
• Knowledge of 21 CFR Part 11, Annex 11, cGMP, GAMP5.

Preferred Skills and Knowledge

• Experience with MES implementation and administration (Emerson Syncade).
• Familiarity with Syncade backend and database design.
• Experience integrating MES with external systems and instruments.
• Knowledge of other systems like ERP, LIMS, CMMS.
• Experience with Computer System Validation (CSV).
• Background in cell and gene therapy manufacturing.
• Strong communication and interpersonal skills.
• Proactive problem-solving and teamwork ability.

The physical and mental demands are typical for this role, including prolonged sitting, movement, visual acuity, and communication skills. Reasonable accommodations are available upon request.