【About the role】
The Equipment Engineer in a pharmaceutical clean room facility is responsible for implementing and maintaining manufacturing equipment, instrumentation, and automation to optimize processes, enhance efficiency, and ensure compliance with regulatory requirements within the clean room environment. This role involves working closely with cross-functional teams to integrate manufacturing solutions, including automation, that support manufacturing operations while adhering to strict quality standards and safety protocols.
【Position Title】 Equipment Engineer - Pharmaceutical Clean Room Facility
【Location】 Taipei, Taiwan
【Reports to】 Associate Director of CMC
【Job Type】 Full-time
【Education /Background】
• Bachelor’s degree in engineering (Chemical, Mechanical, Electrical, or related field) or equivalent experience in engineering within the pharmaceutical industry (5+ years working experiences).
【Responsibilities include, but are not limited to】
1 Develop and implement instrumentation and automation strategies to improve manufacturing operations and ensure consistent product quality within the pharmaceutical clean room environment.
2 Collaborate with process engineers, validation specialists, and quality assurance teams to ensure instrumentation and automation systems meet regulatory requirements (e.g., FDA, GMP) and industry standards (e.g., GAMP).
3 Conduct risk assessments and develop mitigation plans for potential hazards related to instrumentation and automation systems, ensuring compliance with safety regulations and guidelines.
4 Lead the installation, commissioning, and validation of instrumentation and automation equipment and systems in accordance with project timelines and budget constraints.
5 Provide technical support and training to operations and maintenance staff on the use and maintenance of instrumentation and automation systems, including troubleshooting and resolution of issues.
6 Participate in cross-functional teams for the design and implementation of new equipment upgrades, and facility expansions, ensuring seamless integration of instrumentation and automation solutions.
7 Perform periodic audits and assessments of instrumentation and automation systems to identify opportunities for continuous improvement and compliance enhancement.
8 Stay updated on emerging technologies, industry trends, and regulatory changes related to instrumentation and automation in pharmaceutical manufacturing, incorporating best practices into facility operations.
9 Collaborate with vendors and external partners for procurement, installation, and maintenance of instrumentation and automation hardware and software, ensuring alignment with project requirements and quality standards.
