Permanent position for a 2nd shift Engineering Technician ensuring pharmaceutical and medical device process development projects are completed on time and within scope and budget while meeting all technical, quality, regulatory, and safety requirements.
Develop project plans, schedules, and resource requirements by collaborating with Quality, Regulatory, Manufacturing, Supply Chain, and Operations teams.
Ensure designs meet applicable regulatory requirements, quality standards, and company procedures.
Provide technical expertise for equipment selection, process design, automation, and facility improvements.
Engage with installation, commissioning, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes.
Identify project risks and implement mitigation strategies to ensure successful execution.
Drive continuous improvement initiatives focused on productivity, cost reduction, and process optimization.
Support root cause investigations, non-conformance resolution, and corrective and preventive actions (CAPA).
Oversee engineering documentation including specifications, drawings, change controls, and validation reports.
Participate in internal and external audits to ensure compliance with cGMP, FDA QMSR, ISO 13485, and ISO 14971 risk management requirements.
Requirements
At least 4 years of engineering and project experience in a regulated manufacturing or GMP environment.
Strong knowledge of engineering design principles and a good working knowledge of Solid Works and AutoCAD.
Knowledge of cGMP, QMSR, ISO 13485 and ISO 14971 quality systems, and applicable regulatory standards.
Proficiency in project planning tools, data analysis and technical documentation.
Self-starter with excellent interpersonal skills, time management abilities to manage multiple priorities simultaneously, ability to take project ownership, and strong analytical, problem-solving, and decision skills making skills. 2nd shift position: 2:30-11:00pm.
