Senior Manufacturing Engineer

Responsibilities:

Responsible for handling the development of operation protocols for upstream or downstream operations starting from the dispensary of raw materials up to end of the manufacturing process.
Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production
Support Change Records Assessment and GMP documentation Review.
Responsible for providing support to the assigned manufacturing operations by developing, coordinating, and facilitating small to medium projects to ensure planned, predictable production operations in compliance with GMP regulations.
Lead and execute Continuous Process Improvements, CAPAs and Change Records in the assigned area.
Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over.
Lead project teams to troubleshoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance.
Collaborate with multidisciplinary teams to achieve project objectives.
Assist in experimental design and troubleshooting as needed.

Bachelor's degree in a relevant life science or Engineering field (e.g., biology, biotechnology, biochemistry).
At least 5 years of experience in the Manufacturing / GMP environment is preferred.
Strong attention to detail, organizational skills, and the ability to work independently or in a team.
Excellent communication skills, both written and verbal, in English.
Adherence to safety protocols and regulatory compliance.Adherence to safety protocols and regulatory compliance.