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Seeking skilled Scientists and Engineers for consulting services in the life sciences industry. Must have knowledge and experience in cGMP procedures, Quality Risk Assessment, Change Control, Validation, Automation projects, Lean Six Sigma, and project management. Bachelor's degree in sciences or engineering is required.

Provide characterization of process optimization strategies and troubleshooting of operational issues in the biotechnology industry. Apply engineering principles to design and implement system modifications and capital projects. Collaborate with various departments to develop requirements for system modifications and recommendations. Responsible for auditing operational performance and regulatory compliance of equipment and systems.

Responsible for Quality Assurance program support, including New Product Introduction, workorder review, validation protocols, Manufacturing Investigations, risk assessments, and Change Control. Must have strong organizational, project management, and communication skills. Requires 3 years of experience in a similar role.