Project Engineer II - Portsmouth, NH

Unicon Pharma Inc.

Kittery, ME 03904, USA

Published: 6/14/2022

Engineering

Full Time

Description:

MES Engineer is responsible for supporting activities such as requirements gathering, testing, implementation and use of Manufacturing Execution Systems (MES).
Position is expected to operate with some supervision and some autonomy.
Role will primarily be responsible for author and review of test protocol, change execution and testing, and creation of change management processes and procedures for onboardong of a new MODA -ES MES system.

Other responsibilities may include:

Safety

Manufacturing Support

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
Participates in IPT/JPT meetings as MES representative

Projects

Planning and execution 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

Deviations / RCAs

Documentation

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