Process Engineer
2 weeks ago
We are seeking an experienced Senior Process Engineer to lead a strategic initiative aimed at improving the design and robustness of our single-use bioreactor platform. The role focuses on optimizing existing single-use assemblies, associated equipment, and enhancing aseptic handling processes to support upstream manufacturing.
Key Responsibilities:
- Lead cross-functional design reviews of single-use bioreactor platforms to identify areas for improvement and standardization.
- Enhance the layout, installation, and usage of single-use assemblies to optimize aseptic handling and reduce operational risks.
- Drive design enhancements in key areas, including:
- Media feed and waste management
- Aseptic connections and disconnections
- Assembly design and sampling processes
- Procedural controls and operator training
- Oversee the qualification and validation of new and existing process equipment used in conjunction with single-use systems.
- Develop and execute qualification protocols, ensuring adherence to Good Manufacturing Practices (GMP).
- Document all qualification activities using electronic documentation systems.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to resolve discrepancies and implement corrective actions.
- Lead initiatives to optimize processes for scalability, robustness, and reliability of single-use technologies.
- Contribute to the development of procedural documentation, training materials, and best practices for single-use systems in the manufacturing process.
Requirements
Qualifications:
- Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, or a related discipline.
- Minimum of 7 years of experience in biopharmaceutical manufacturing, with a focus on upstream processes and single-use technologies.
- Expertise in process design, equipment qualification, and validation within a GMP environment.
- Hands-on experience with single-use bioreactor systems and related process equipment.
- Strong understanding of aseptic processing principles, including media feed, waste stream management, and aseptic connections.
- Proficiency in electronic documentation systems for authoring and managing qualification protocols.
- Demonstrated ability to lead cross-functional projects from design through implementation.
- Excellent problem-solving skills, attention to detail, and proactive risk management.
- Strong communication and presentation skills for effective stakeholder engagement.
Preferred Qualifications:
- Experience with process optimization and design improvements for single-use technologies in large-scale biopharmaceutical manufacturing.
- Familiarity with qualification of equipment used in single-use system integration.
Experience in developing and reviewing procedural controls and training programs for manufacturing operations.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
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