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 developing, executing, and managing validation activities for utilities systems in compliance with regulatory requirements and internal quality standards
• Ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air and HVAC. 
• Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Provides technical and sustaining engineering support in a manufacturing area
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products
• Integrates equipment and material capabilities to meet process module target specifications and technology target specifications
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules
• Interacts with product design and development personnel to ensure that processes and designs are compatible
• May develop and conduct statistical analysis or recommend additions to document work
• Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems
• Ensures processes and procedures are in compliance with regulations. 
• Responsibility in our technical functions to advance existing technology or introduce new technology and therapies
• Formulates, delivers and or manages projects assigned and works with other stakeholders to achieve desired results

Qualifications:

• Bachelor or technical degree in science or engineering
• 5+ years of relevant experience
• Experience with Utilities Equipment, Regulatory and Compliance Systems, Technical Writing, Troubleshooting, Agile Systems, SAP Systems
• Knowledge of Validation Qualification Phases and Commissioning
• Experience with Air Compressors and Mechanical Equipment's Knowledge
• Experience in utilities validation and a thorough understanding of GMP regulations
• Validation of facilities and utilities equipment including air compressor and HVAC system
• FDA and ISO regulated industry experience
• Operational SOP, validation protocols and maintenance plan
• Availability for 1st shift