MES Engineer

TekWissen•Portsmouth, NH

4d•Onsite

About The Position

The MES Engineering Contractor I supports the configuration and delivery of Manufacturing Execution System (MES) electronic batch records (eBRs), with a focus on campaign readiness. The role configures parameters, generates change requests, manages eBR schedules, and coordinates customer reviews and approvals so records meet established Batch Record Issue (BRI) dates. The contractor coordinates delivery activities across campaigns and works with MES Engineers, Process Scientists, Manufacturing Supervision, customers, and other stakeholders. The role operates within established policies and procedures, with detailed instructions provided for new projects and assignments. Work is performed onsite in an office setting during regular office hours, with adherence to cGMP and site safety requirements.

Requirements

Bachelor’s degree or equivalent in a STEM field.
Required English language proficiency.
Entry-level Pharma/Biotech work experience; the posting specifies 0–4 years.
Ability to communicate effectively at all levels.
Ability to obtain relevant information and identify key issues and relationships from available information.
Ability to evaluate engineering problems, determine cause-and-effect relationships, and propose solutions.
Ability to follow instructions, interpret data, draw conclusions, and recommend action steps.
Must follow applicable cGMP, job safety, and company/site safety requirements.

Responsibilities

Configure and maintain electronic batch records, including Bill of Parameters configuration, and generate required change requests.
Coordinate eBR delivery across campaigns to ensure records are configured, reviewed, approved, and available to Manufacturing by established BRI dates.
Participate in project and campaign readiness meetings to align scope, schedules, dependencies, and deliverables across functional groups.
Support accurate, Right-First-Time eBR execution through configuration and cross-functional collaboration.
Coordinate customer and stakeholder participation in eBR reviews and approvals, manage comments, resolve questions, clarify requirements, and track outstanding actions.
Facilitate meetings and escalate risks or roadblocks that could affect eBR delivery or campaign readiness.
Maintain and communicate campaign eBR delivery schedules, track milestones and approvals, identify risks to BRI dates, coordinate dependencies, and escalate schedule risks.
Perform other duties as assigned.
Follow job safety procedures, complete required health and safety training, promote workplace safety, report actual and potential accidents and injuries, and comply with company and site safety policies.
Adhere to cGMP requirements and promptly notify responsible management of regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions.