Manufacturing Execution Systems (MES) Engineer - Cell and Gene Therapy

About the position

The MES Engineer Level 2 at Lonza is responsible for supporting the implementation and operation of Manufacturing Execution Systems (MES) within a GMP environment. This role involves a combination of technical support, project management, and quality assurance, requiring both autonomy and supervision. The engineer will work closely with manufacturing teams to troubleshoot equipment issues, manage process improvements, and ensure compliance with quality standards.

Responsibilities

• Perform all work safely and meet requisite training requirements.
• Develop technical knowledge on manufacturing equipment and process automation systems.
• Manage resolution of equipment breakdowns and quality issues in the suites.
• Provide SME support to Manufacturing and other departments for the design and operation of process equipment.
• Conduct troubleshooting and technical analyses on manufacturing equipment and process control systems including PI data analyses, CIP/SIP circuit review, flow path analyses, code review/troubleshooting, etc.
• Assist with tech transfer of new processes into the facility.
• Complete change request lot assessments to support lot release.
• Participate in IPT/JPT meetings as MES representative.
• Plan and execute plant projects involving automation changes and process improvements including lump sum capital projects.
• Execute test scripts (design, execution, simulation, wet testing).
• Own change requests and complete change request tasks to support project completion.
• Perform change request assessments.
• Assist the Quality department with deviation investigations.
• Participate in RCAs as MES representative.
• Assist with completion of CAPA actions.
• Participate in quality risk assessments.
• Review/revise automation and Manufacturing related SOP's, Functional Specifications, and work instructions as a result of CAPA, equipment/process changes, error prevention activities, etc.
• Complete MES review/approval of batch records.
• Author and review test protocols.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in an engineering or related discipline.
• Related work experience in a GMP environment.
• Strong communication and leadership skills.
• Ability to secure relevant information and identify key issues and relationships from a base of information.
• Ability to evaluate engineering problems and devise cause and effect relationships and propose solutions.
• Ability to fulfill on-call hours requirements.