LL01-100924 Process Engineer for Aseptic Filling - Validation & Engineering Group

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Process Engineer – Aseptic Filling, Isolators, Inspection, and Packaging

We are seeking a dedicated and skilled Process Engineer with expertise in aseptic filling processes, isolators, inspection systems, and packaging lines to support our commercial pharmaceutical manufacturing operations. This role will ensure the effective and compliant functioning of aseptic manufacturing operations, focusing on optimizing processes, troubleshooting issues, and ensuring regulatory compliance.

Responsibilities:

Aseptic Filling:

• Lead and optimize aseptic filling operations to ensure compliance with cGMP, safety, and quality standards.
• Develop, implement, and maintain procedures for aseptic processing, ensuring sterile product integrity.
• Monitor environmental controls and ensure that all aseptic processes are validated and consistent.

Commercial Lines:

• Support the installation, validation, and operation of commercial manufacturing lines for pharmaceuticals.
• Provide technical support for the commercial line, ensuring maximum efficiency and minimal downtime.
• Analyze and improve processes related to throughput, quality, and product safety.

Isolators:

• Design and implement isolator processes, ensuring that they meet all sterility and containment requirements.
• Perform routine assessments and validation of isolators to ensure optimal performance.
• Support maintenance and calibration activities for isolators to ensure ongoing compliance.

Inspection Systems:

• Optimize inspection systems for both manual and automated processes to maintain product quality and regulatory standards.
• Troubleshoot and resolve issues with inspection systems, ensuring continuous product quality control.
• Evaluate and implement new technologies or enhancements for visual inspection, particle detection, and automated inspections.

Packaging:

• Oversee the packaging process, ensuring that packaging is efficient, compliant, and cost-effective.
• Optimize packaging equipment performance, reducing waste and ensuring product protection.
• Lead packaging validation efforts, including the implementation of new packaging designs and materials.

Compliance and Documentation:

• Ensure compliance with FDA, EMA, and other relevant regulatory standards (e.g., cGMP, ISO).
• Prepare and maintain detailed documentation of all processes, including validation protocols, batch records, and process improvements.
• Participate in audits and inspections, providing technical support and ensuring that all operations adhere to regulatory requirements.

Continuous Improvement:

• Lead or participate in continuous improvement initiatives to enhance the performance of the aseptic filling, isolators, inspection, and packaging systems.
• Utilize lean manufacturing, Six Sigma, or other process improvement methodologies to drive efficiency.
• Collaborate cross-functionally with quality assurance, maintenance, and operations teams to achieve optimal outcomes.

Qualifications:

• Bachelor’s degree in Engineering, Biotechnology, or a related field. Advanced degrees are a plus.
• 5+ years of experience in a process engineering role within pharmaceutical or biopharmaceutical manufacturing, focusing on aseptic filling, isolators, and packaging.
• Strong understanding of cGMP and regulatory requirements for sterile product manufacturing.
• Hands-on experience with isolator technology, aseptic processing, and automated packaging/inspection systems.
• Knowledge of process validation, equipment qualification, and risk management principles.
• Excellent problem-solving, communication, and project management skills.
• Certification in lean manufacturing, Six Sigma, or similar process improvement methodologies is a plus.
• Willing to travel to USA and Europe if needed.

Key Skills:

Aseptic Filling | Isolators | cGMP | Process Optimization | Packaging Lines | Inspection Systems | Continuous Improvement | FDA & EMA Compliance | Equipment Validation | Troubleshooting