Sounds interesting?
Apply NowABOUT THE ROLE
Thor Companies is representing a leading client in the biotech industry, seeking a Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for implantable Class III medical devices. This role focuses on scaling up production, enhancing efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques. The successful candidate will play a pivotal role in troubleshooting production challenges, driving continuous improvement initiatives, and ensuring compliance with regulatory standards.
Key Responsibilities
Your responsibilities will include, but are not limited to:
Process Design and Development:
Lead the design, development, and optimization of manufacturing processes for new and existing implantable Class III medical devices.
Collaborate with manufacturing teams and external partners to define and implement efficient, scalable, and compliant production processes.
Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
Process Validation and Qualification:
Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, FDA 21 CFR Part 820) and meet quality requirements.
Analyze and document validation results, addressing any deviations or non-conformances.
Collaborate with equipment and maintenance teams to ensure manufacturing equipment is maintained, calibrated, and optimized.
Continuous Improvement and Optimization:
Identify, lead, and execute projects aimed at improving process efficiency, reducing waste, and enhancing product quality.
Perform root cause analyses for process failures or deviations and implement corrective and preventive actions (CAPAs) in collaboration with the Quality Department.
Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Production, to align on process requirements and timelines.
Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.
Monitor process performance by collecting and analyzing production data, identifying areas for improvement.
Generate reports, metrics, and presentations summarizing process performance, validation activities, and improvement initiatives.
Regulatory Compliance and Documentation:
Ensure all production processes comply with medical device regulations and standards, including FDA, GMP, ISO, and other applicable guidelines.
Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.
Support audits and regulatory inspections by providing technical expertise and required documentation.
Equipment Management and Maintenance:
Collaborate with equipment and maintenance teams to ensure optimal performance and calibration of manufacturing equipment.
Support the installation and validation of new equipment, ensuring alignment with process requirements and regulatory standards.