PROCESS ENGINEER II

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