Project Engineer

Unicon Pharma Inc; Portsmouth (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

Unicon Pharma Inc is seeking an MES Engineer Level I to support the rollout and ongoing maintenance of Manufacturing Execution Systems across production suites. You will gather requirements, test, implement, and ensure MES tools operate effectively in manufacturing environments.

You will troubleshoot equipment and process automation, provide SME support to Manufacturing and other departments, assist with tech transfers, CAPA closures, and document changes to SOPs and specifications to support

Qualifications

• Ability to effectively communicate at all levels.
• Ability to secure relevant information and identify key issues and relationships from a base of information.
• Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.

Responsibilities

• Develop technical knowledge on manufacturing equipment and processes automation systems.
• Support 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 automation equipment.
• Conduct troubleshooting and technical analyses on manufacturing equipment and processes automation systems including PI data analyses, review/troubleshooting code, etc.
• Assist with tech transfer of new processes into the facility.
• Complete change request lot assessments to support lot release.
• Assist with the planning and execution of plant projects involving automation changes and process improvements.
• Execute test scripts (design, execution, simulation, wet testing, etc.) with support and guidance from supervisor.
• Own change requests and complete change request tasks to support project completion.
• Assist the Quality department with deviation investigations.
• Participate in RCAs as MES representative.
• Assist with completion of CAPA actions.
• 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.

Skills

Communication

Info gathering

Problem solving

Job description

Key Accountabilities:

• The MES Engineer Level I is responsible for supporting activities such as requirements gathering, testing, implementation and use of Manufacturing Execution Systems (MES).

Safety

• Performs all work safely and meets the requisite training requirements.

Manufacturing Support

• Develop technical knowledge on manufacturing equipment and processes automation systems
• Support 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 automation equipment.
• Conduct troubleshooting and technical analyses on manufacturing equipment and processes automation systems including PI data analyses, review/troubleshooting code, etc.
• Assist with tech transfer of new processes into the facility
• Complete change request lot assessments to support lot release

Projects

• Assist with the planning and execution of plant projects involving automation changes and process improvements
• Execute test scripts (design , execution, simulation, wet testing, etc.) with support and guidance from supervisor
• Own change requests and complete change request tasks to support project completion

Deviations / RCAs

• Assist the Quality department with deviation investigations
• Participate in RCAs as MES representative
• Assist with completion of CAPA actions

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.

Skills:

• Ability to effectively communicate at all levels
• Ability to secure relevant information and identify key issues and relationships from a base of information.
• Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions