Sr. Manufacturing Engineer

MG STAFFING GROUP•Juncos, PR

12d•Onsite

About The Position

Responsibilities: Assess the impact of IT reports, applications, software, and hardware changes on manufacturing processes and equipment. Plan, execute, and document Computer Systems Validation (CSV) activities, including validation protocols, execution, and final reports. Implement and support manufacturing procedures and documentation changes. Inspect machinery, equipment, and tools to verify operational efficiency and performance. Investigate equipment and process deficiencies and initiate corrective actions to ensure product quality. Ensure manufacturing processes and procedures comply with regulatory and quality system requirements. Deliver and manage assigned engineering projects in collaboration with cross-functional teams. Contribute to department and work group objectives through effective collaboration and stakeholder engagement. Provide technical guidance, coaching, and review of work for lower-level engineers or specialists. Communicate with senior internal stakeholders and external vendors to exchange technical information and influence decision-making. Other duties maybe assigned. Requirements Requirements: Bachelor’s Degree in Engineering required. Minimum 4 years of relevant manufacturing engineering experience, or Minimum 2 years of experience with an advanced engineering degree. Demonstrated experience performing Computer Systems Validation (CSV) in a regulated environment. Experience assessing and managing manufacturing and IT-related system changes. Proven experience leading technical initiatives or projects. Strong understanding of regulatory compliance requirements. Ability to manage complex technical issues involving multiple systems or processes. Effective communication skills for interaction with internal and external stakeholders. Skills: Computer Systems Validation (CSV) IT Systems Knowledge (manufacturing-related) Manufacturing Engineering Equipment Performance Evaluation Process and Procedure Changes Regulatory Compliance (cGMP / Quality Systems) Technical Leadership Project Management Root Cause Analysis & Corrective Actions Cross-Functional Collaboration Technical Documentation Stakeholder Communication Work Schedule & Availability: Full-time, onsite position. Availability to work extended shifts (8–12 hours). Availability to work weekends and holidays as required. Availability to work 1st and/or 2nd shift (primarily 1st shift).

Requirements

Bachelor’s Degree in Engineering required.
Minimum 4 years of relevant manufacturing engineering experience, or
Minimum 2 years of experience with an advanced engineering degree.
Demonstrated experience performing Computer Systems Validation (CSV) in a regulated environment.
Experience assessing and managing manufacturing and IT-related system changes.
Proven experience leading technical initiatives or projects.
Strong understanding of regulatory compliance requirements.
Ability to manage complex technical issues involving multiple systems or processes.
Effective communication skills for interaction with internal and external stakeholders.
Computer Systems Validation (CSV)
IT Systems Knowledge (manufacturing-related)
Manufacturing Engineering
Equipment Performance Evaluation
Process and Procedure Changes
Regulatory Compliance (cGMP / Quality Systems)
Technical Leadership
Project Management
Root Cause Analysis & Corrective Actions
Cross-Functional Collaboration
Technical Documentation
Stakeholder Communication

Responsibilities

Assess the impact of IT reports, applications, software, and hardware changes on manufacturing processes and equipment.
Plan, execute, and document Computer Systems Validation (CSV) activities, including validation protocols, execution, and final reports.
Implement and support manufacturing procedures and documentation changes.
Inspect machinery, equipment, and tools to verify operational efficiency and performance.
Investigate equipment and process deficiencies and initiate corrective actions to ensure product quality.
Ensure manufacturing processes and procedures comply with regulatory and quality system requirements.
Deliver and manage assigned engineering projects in collaboration with cross-functional teams.
Contribute to department and work group objectives through effective collaboration and stakeholder engagement.
Provide technical guidance, coaching, and review of work for lower-level engineers or specialists.
Communicate with senior internal stakeholders and external vendors to exchange technical information and influence decision-making.
Other duties maybe assigned.