Drug Product Process Engineer
1 week ago
We are seeking a highly skilled Technical Development Specialist to join our team. This is an exciting opportunity to work on cutting-edge manufacturing processes and sites, providing quality assurance and control to ensure compliance with regulatory standards.
Key Responsibilities:- Support filling operations in a matrix team environment, working closely with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams.
- Develop process comparisons and risk assessments, manage technical and manufacturing risks, and identify appropriate mitigations.
- Author technical reports to support process and product characterization.
- Manage change control, deviations, and CAPAs through the quality management system until closure.
- Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations.
- Strong understanding and hands-on experience in MSAT or process development or technology transfer, background in large-scale processing of biologic drug products.
- Possess a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products.
- Have a solid understanding of regulatory requirements and guidelines.
- Proficient in technical writing.
- Demonstrated ability to build strong partnerships and work effectively with diverse team members in a dynamic environment.
- Excellent organizational, interpersonal communication, and problem-solving skills.
- Capable of identifying, communicating, and implementing continuous process improvements.
- Ability to multi-task and manage tight timelines in a fast-paced environment.
- Able to work on the manufacturing floor for extended periods during the execution of technical protocols.
- Excellent written, verbal, and presentation communication skills.
- Strong analytical skills and sound judgment.
- Effective decision-making skills, with the ability to negotiate and balance decisions and priorities across multiple stakeholders' needs.
- Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project, etc.
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