Senior Process Engineer

Senior Process Engineer

Msd International Gmbh (singapore Branch)
2-5 years
54000 - 90000 SGD

Job Description

The Senior Process Engineer will be reporting into the Engineering Services department but will be serving as a liaison between the project team and other departments.


WHAT YOU WILL DO

· Provide technical, commissioning, qualification, and validation expertise for the manufacturing of all drug substances on-site about the migration of the Distributed Control System (DCS), this involves installing a new DCS system and obsoleting the existing one to address identified compliance gaps

· Support effort to develop/review/approve all project execution/systems life cycle document deliverables including, but not limited to Plans (QAP, Test, Migration, Execution), Specifications (Design, Configuration, Functional, Requirements), Assessments (Risk, Gap), Reviews (design, code), Test Protocols (FAT, SAT, UAT, IQ, OQ, PQ), Traceability Matrices and Reports (validation summary, progress)

· Lead the process team within the project/site for all works associated with process improvement and remediating DCS compliance gap, ensure process-specific requirements are met in the new DCS system

· Lead and/or support the implementation of change controls from DCS migration: impact assessment, perform reviews, manage project schedule, test plan, resource plan, vendor coordination

· Lead and support commissioning and qualification activities including developing, review and implement equipment and process OQ protocol

After one year, you will

· Work independently and take decisions based on available information

· Understand how to coordinate different functions

· Communicate with external vendors


WHAT YOU MUST HAVE

· Minimum 3 to 5 years of experience in the pharmaceutical industry.

· Bachelor Degree in Engineering

· Good knowledge of applicable safety and GMP regulations

· Able to facilitate smooth communication between project and stakeholders

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