Katalyst Healthcares and Life Sciences
Responsibilities:
- We are seeking a Senior Quality Engineer with a strong background in IV bag or IV solutions manufacturing to join our healthcare manufacturing team. The ideal candidate will have experience in a regulated manufacturing environment, with a focus on quality engineering processes related to IV solutions or sterile product manufacturing.
- Candidates with an engineering background or relevant chemistry experience are highly preferred. This role requires a hands-on approach to ensure that all products meet the highest quality standards while maintaining regulatory compliance.
- Lead quality engineering activities for the manufacturing of IV bags or IV solutions, ensuring products meet regulatory standards (e.g., FDA, ISO).
- Provide expertise in manufacturing processes, focusing on process improvement, validation, and troubleshooting for IV solution production.
- Collaborate with cross-functional teams, including manufacturing, R&D, and quality assurance, to address quality-related issues and implement corrective actions.
- Develop, review, and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and products in a sterile manufacturing environment.
- Investigate non-conformance issues, deviations, and root causes in the manufacturing process, ensuring timely and effective resolution.
- Conduct risk assessments, including Failure Mode and Effects Analysis (FMEA), and develop mitigation strategies to enhance product quality.
- Support continuous improvement initiatives within the manufacturing process to enhance product consistency, reduce waste, and improve efficiency.
- Ensure compliance with Good Manufacturing Practices (GMP), and other relevant regulatory guidelines.
- Review and approve quality documentation, including batch records, standard operating procedures (SOPs), and validation reports.
- Provide technical leadership and guidance to junior engineers and quality personnel.
- Bachelor's degree in engineering (Mechanical, Chemical, Industrial, or related field) or Chemistry; advanced degree preferred.
- Minimum of 5 years of experience in quality engineering, with a focus on IV bag or IV solutions manufacturing.
- Proven expertise in quality systems, process validation, and risk management in a sterile manufacturing environment.
- Strong knowledge of regulatory standards and requirements (FDA, ISO 13485, GMP) for medical devices or pharmaceutical manufacturing.
- Hands-on experience with manufacturing process troubleshooting, root cause analysis, and corrective action implementation.
- Excellent analytical skills, with the ability to solve complex problems and make data-driven decisions.
- Strong communication and leadership skills, with the ability to work effectively in a cross-functional team environment.
- Proficiency in quality management systems and continuous improvement tools (e.g., Six Sigma, Lean Manufacturing).
- Certification in quality engineering (CQE) or Six Sigma.
- Experience in automated manufacturing systems and process control.
- Familiarity with IV fluid sterility testing, environmental monitoring, and microbiological control.