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Biologics Manufacturing Specialist
2 weeks ago
We are seeking a Process Engineer to support new product introduction, technology transfer, and process optimization in biologics manufacturing. This is an exciting opportunity for a skilled engineer to join our organization and drive innovation in the field.
Key Responsibilities:- Lead technical investigations and corrective actions to ensure high-quality outcomes.
- Drive Lean Six Sigma projects and process improvements to enhance efficiency and productivity.
- Support upstream and downstream process design and qualification to meet regulatory standards.
- Analyze process data for yield and robustness to inform business decisions.
- Partner with cross-functional teams to deliver results-driven solutions.
- Ensure compliance with cGMP, audits, and regulatory standards through effective risk management.
- Degree in Pharmaceutical, Biological, Chemical Sciences, or Engineering.
- Experience in biologics manufacturing (upstream/downstream) with a proven track record of success.
- Knowledge of automation systems and process monitoring to optimize performance.
- Strong skills in Lean Six Sigma, Change Management, and deviations/corrective actions to drive business growth.
- Excellent communication, problem-solving, and team player skills to collaborate effectively.