Automation Engineer (Pharmaceutical Manufacturing MNC, Office Hours 5 Days)

Job ResponsibilitiesProvide automation support to Manufacturing Operations as part of the Process Automation group, focused on the Manufacturing Control System (MCS) to implement continuous improvement changes, support MAR (Make Assess Release) activities, and assist on capital projects. Responsibilities include: Provide automation design and support for the MCS. Work with Manufacturing, Quality, and MSAT departments to implement corrective actions and continuous improvement changes, and support capital projects. Perform Quality discrepancy evaluations/assessments and provide support for Investigations. Perform troubleshooting and provide support for MCS system and software issues. Perform off-line and on-line coding, commissioning, and qualification. Review, revise, and approve automation design documents, and automation functional requirement documents. Assist with equipment testing and debug activities. Review and assess change records, risk assessments, and user requirements. Represent automation engineering on multidisciplinary and cross-functional project teams. Support and/or lead development and execution of automation change records (CRs and ACRs) and execute control qualification/commissioning test documentation. Perform cGMP reviews of executed Automation Work Plans and tests for completeness and accuracy. Job Requirements Min BS/MS/PhD degree in Chemical Engineering, Electrical Engineering, Mechatronic Engineering, Mechanical Engineering, or Computer Science. A minimum of 2 years of experience in the design, implementation and/or support of instrumentation and control systems, preferably in the Bio-Pharmaceutical, Pharmaceutical, food or other batch processing industries would be at an advantage Experience with distributed control system, software development methodologies and automated system life cycle support in a regulated industry. Familiarity with Instrumentation, Systems, and Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems. Thorough understanding of cGMP’s particularly as they relate to the operation, validation and maintenance of computer-controlled systems. Leon Leong De Cong R1551708