Position Summary The Senior Engineer is responsible for providing advanced engineering support to manufacturing operations in a regulated environment. This role focuses on process optimization, troubleshooting, and implementation of continuous improvement initiatives to ensure efficient, compliant, and reliable production processes. The Senior Engineer partners cross-functionally with Operations, Quality, and Maintenance teams to drive operational excellence and technical solutions.
Key Responsibilities - Provide engineering support to manufacturing operations, ensuring process reliability, efficiency, and compliance with regulatory requirements.
- Lead and support troubleshooting and root cause investigations for process and equipment issues.
- Develop and implement corrective and preventive actions (CAPA).
- Drive continuous improvement initiatives using methodologies such as Lean Six Sigma, Kaizen, and root cause analysis.
- Support process optimization and technology improvements to enhance performance and reduce variability.
- Collaborate with cross-functional teams (Operations, Quality, Maintenance) to ensure alignment and successful execution of initiatives.
- Ensure adherence to cGMP standards, regulatory requirements, and documentation practices.
- Participate in risk assessments, change control processes, and validation activities as required.
- Support audits, inspections, and regulatory interactions.
- Maintain technical documentation and generate reports to communicate findings and recommendations.
Qualifications - Doctorate degree OR
- Master's degree + 2 years of Engineering experience OR
- Bachelor's degree in Engineering + 4 years of Engineering experience
- Academic background in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology
- Experience in manufacturing operations within regulated industries such as biotech, pharmaceutical, or similar
- Hands-on experience in process engineering, production support, or manufacturing systems
- Knowledge of automation systems and process equipment
- Experience with continuous improvement methodologies (Lean Six Sigma, Kaizen)
- Strong root cause analysis and problem-solving skills
- Experience implementing CAPA and process optimization strategies
- Understanding of cGMP regulations, compliance, and documentation practices
