Process Engineer

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)