MES Engineer Level 2

Lonza•Portsmouth, NH

2d•Onsite

About The Position

Lonza is seeking an experienced MES Engineer Level 2 to join their team in Portsmouth, NH. This role involves supporting manufacturing operations, developing technical knowledge of equipment and automation systems, and managing the resolution of equipment breakdowns and quality issues. The engineer will provide Subject Matter Expert (SME) support for process equipment design and operation, conduct troubleshooting and technical analyses, and assist with tech transfer of new processes. Responsibilities include managing change requests, participating in project planning and execution for automation changes and process improvements, and executing test scripts. The role also involves assisting the Quality department with deviation investigations, CAPA actions, and quality risk assessments, as well as reviewing and revising automation and manufacturing-related SOPs and specifications. Experience with electronic batch records (eBR), Syncade recipe authoring, and integration of MES with systems like SAP, DeltaV, and Trackwise is essential. A strong understanding of GMP, data integrity, and cGMP documentation standards is required for compliance.

Requirements

Bachelor’s degree, or foreign equivalent degree in Chemical Engineering or Biotechnology: Industrial and Biomedical Sciences
Two (2) Years of experience in the job offered or two (2) Years of experience in a related occupation processing automation systems, performing PI data analysis, reviewing CIP/SIP circuits and flow paths, and supporting system testing, change controls, and quality investigations (CAPA, RCA, deviations)
Using GMP, data integrity, and cGMP documentation standards is required to ensure compliance.
Master’s degree in Chemical Engineering or Biotechnology: Industrial and Biomedical Sciences
Experience, project experience, or course work in processing automation systems, performing PI data analysis, reviewing CIP/SIP circuits and flow paths, and supporting system testing, change controls, and quality investigations (CAPA, RCA, deviations)
Using GMP, data integrity, and cGMP documentation standards is required to ensure compliance.

Responsibilities

Performs all work safely and meets the 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 of 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.
Utilize electronic batch record (eBR) design, Syncade recipe authoring, and recipe object management, along with exposure to integration of MES with systems such as SAP (MM, PP, SD), DeltaV, and Trackwise.
Process automation systems, perform PI data analysis, review CIP/SIP circuits and flow paths, and support system testing, change controls, and quality investigations (CAPA, RCA, deviations).
Use GMP, data integrity, and cGMP documentation standards is required to ensure compliance.