QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Responsible for production support engineering with respect to testing methods, procedures, and problems; device/product and yield problems; analysis of product rejection; supplier related engineering changes and optimizing production relative to cost constraints.
- Supports manufacturing operations by assisting with IT system upgrades, computer system validation activities, and controlled documentation updates related to manufacturing equipment and processes.
- Assist with documentation updates and change control activities related to manufacturing systems and processes.
- Ensure compliance with internal quality systems, validation procedures, and regulatory standards.
- Collaborate with cross-functional teams including IT, Manufacturing, Engineering, and Quality to support project execution..
- Bachelor's degree in engineering
- Minimum 2 years of relevant experience in manufacturing, engineering, validation, or related environments.
- Ability to support project schedules including overtime and weekend work when required.
- Computer System Validation (CSV)
- Manufacturing Equipment System Integration
- IT Systems in Manufacturing Environments
- Validation Documentation and Change Management
Skills Required
- Bachelor's degree in engineering
- Minimum 2 years of relevant experience in manufacturing, engineering, validation, or related environments
- Ability to support project schedules, including overtime and weekend work when required
- Computer System Validation (CSV) experience
- Manufacturing equipment system integration experience
- Experience with IT systems in manufacturing environments
- Validation documentation and change management experience
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
