Process Engineer

We are seeking a highly skilled Process Engineer with specialized experience in aseptic techniques to join our pharmaceutical manufacturing team. In this role, you will be responsible for designing, optimizing, and ensuring the integrity of aseptic manufacturing processes to uphold product sterility and quality.

Key Responsibilities:
Aseptic Process Design:

Lead the design and development of aseptic processing systems and procedures, ensuring compliance with industry standards and regulatory requirements.
Cleanroom Operations:

Oversee cleanroom activities, including environmental monitoring, gowning procedures, and disinfection protocols to maintain a sterile manufacturing environment.
Sterilization Methodologies:

Evaluate and implement appropriate sterilization methods for equipment and materials used in aseptic processing, such as steam sterilization, gamma irradiation, and vaporized hydrogen peroxide (VHP).
Media Fills and Validation:

Plan and execute media fill studies and process validations to demonstrate the effectiveness of aseptic manufacturing processes and ensure product sterility.
Risk Assessment and Mitigation:

Conduct risk assessments related to aseptic processes and implement strategies to minimize contamination risks and ensure product safety.
Training and Compliance:

Develop training programs on aseptic techniques and Good Manufacturing Practices (GMP) for manufacturing personnel. Ensure adherence to regulatory requirements and quality standards.
Continuous Improvement:

Implement continuous monitoring of aseptic processes, analyze data, and initiate improvements to enhance process reliability, efficiency, and quality.

Qualifications and Skills:
Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, or related field.
In-depth knowledge of aseptic processing principles, cleanroom operations, and sterilization methods.
Experience with process validation, risk assessment, and compliance with regulatory standards (GMP, FDA, etc.).

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