Project Engineer II

Company : Katalyst HealthCares & Life Sciences

Location : Portsmouth, NH, 00215

Posted Date : 1 October 2025

Job Type : Other

Category : Project Management

Occupation : Project Engineer

Job Details

Job 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 onboarding of a new MODA -ES MES system.
Responsibilities:

Performs all work safely and meets the requisite training requirements.
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.
ssist 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.
ssist the Quality department with deviation investigations.
Participate in RCAs as MES representative.
ssist with completion of CAPA actions.
Participates in quality risk assessments.

Requirements:

Review/revise automation and Manufacturing related SOP's, Functional Specifications, and work instructions because of CAPA, equipment/process changes, error prevention activities, etc.
Complete MES review/approval of batch records.
uthor and review test protocols.
College degree required.