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:
- Provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
- Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
- Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity
- Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
- Initiate and complete routine technical tasks.
- Function as a technical expert to equipment or systems regarding troubleshooting operations.
- Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
- Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
Qualifications:
- Bachelor’s degree in Mechanical, Electrical and/or Chemical Engineering
- Preferably, resource should have experience in GMP-related field (manufacturing operations, engineering operations).
- Two (2) years of Engineering experience
- Capable of resolving equipment related problems by using technical skills to analyze the condition, understand variables that impact the process, and propose and resolve issue.
- Understand control systems (input, output, control). Experience in drug substance/API operations.
- Preferred experience in equipment start up, troubleshooting, PLC.
- Able to understand manufacturing equipment, failure modes and troubleshoot equipment (valves, pumps, utilities systems).
- Ability to apply engineering science to production.
- Non-Standard Shift 12hrs (5pm to 5am)
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
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