About the role
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: * Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment * Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications. * Work with project managers to complete design and engineering projects within schedule, budget and quality constraints. * Coordinate the work of consultants, architects and engineering firms on development of standard design documents. * Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project * Develop engineering policies and procedures that affect multiple organizational units. * Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. * Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise. * Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields. * Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Qualifications: * Bachelor’s degree in Engineering Required. * Proven experience performing technical assessments of equipment in a regulated pharmaceutical, biotechnology, or manufacturing environment. * Experience preparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications. * Demonstrated ability to evaluate equipment failures, performance issues, maintenance history, operating conditions, and potential impacts to product quality, processes, equipment qualification status, and intended use. * Experience providing technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitment activities. * Knowledge of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use. * Ability to review and interpret engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data. * Strong technical writing skills, with the ability to develop clear, factual, scientifically sound, and evidence-based conclusions and recommendations. * Experience collaborating cross-functionally with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to gather and evaluate technical information. * Working knowledge of cGMP requirements and the ability to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence. * Strong analytical, problem-solving, organizational, and communication skills. * Ability to independently manage multiple technical assessments, priorities, and deliverables while meeting established timelines. * Experience with purification systems, fermentation equipment, process equipment, utilities, or pharmaceutical manufacturing systems is preferred. * Strong field presence and willingness to inspect equipment, interact with manufacturing personnel, and verify actual operating conditions within manufacturing areas. * Ability to work effectively in a highly regulated environment and maintain a high level of attention to detail and documentation quality. * Administrative Shift