Position Overview:Technical & Engineering Consulting is seeking a Principal Process Scientist to provide specialized support for their sterile manufacturing operations. This resource will act as a Subject Matter Expert in liquid and lyophilized parenteral processes, supporting ongoing operations, troubleshooting, process optimization, and technology transfer initiatives while ensuring strict compliance with cGMP standards.
Key Responsibilities:- Serve as SME for sterile manufacturing processes, including liquid and lyophilized parenteral products.
- Support daily manufacturing operations, troubleshooting, and investigations (e.g., deviations, CAPAs).
- Lead and contribute to process validation activities and technology transfer projects.
- Identify opportunities for process improvements and optimization.
- Collaborate cross-functionally with Manufacturing, Engineering, Quality, and Validation teams.
- Ensure compliance with site procedures and regulatory standards.
Qualifications:- Degree in Science, Chemical Engineering, or related discipline.
- Experience in pharmaceutical sterile manufacturing environments.
- Strong knowledge of cGMP regulations, process validation, and technology transfer principles.
- Proven problem-solving and troubleshooting skills.
- Excellent communication and collaboration abilities.
