Team Member - Process Engineering

Job Summary
We are looking for a Team Member Process Engineering in MSAT for coordinating preventive maintenance schedules, overseeing external contractors, and ensuring compliance with safety and quality standards. They review production operations, train team members, manage spare parts inventory, and lead troubleshooting efforts to minimize downtime. Additionally, they maintain budgets, support technical activities, and ensure regulatory compliance, contributing to the efficient and reliable operation of equipment and facilities.

Roles & Responsibilities
• You will be responsible for overseeing all operations in accordance with established SOPs, protocols, and any cGMP documents, ensuring data is captured in relevant documents following Good Documentation Practices.
• You will be responsible for performing risk analysis before implementing any changes in the production area to mitigate potential hazards or disruptions.
• You will be responsible for ensuring assimilation, qualification, and validation of new processes or technologies in production, documenting and sharing findings with relevant team members.
• You will be responsible for improving yields, solvent recovery, waste reduction, and other production objectives to enhance operational efficiency.
• You will be responsible for initiating and closing change control action plans to manage modifications effectively within the production environment.
• You will be responsible for enhancing quality in both process and finished goods through continuous improvement initiatives.
• You will be responsible for investigating incidents, out-of-specification (OOS), out-of-trend (OOT) occurrences, and complaints to identify root causes and implement corrective actions.
• You will be responsible for troubleshooting issues to ensure process robustness, aiming to find permanent solutions for operational challenges.
• You will be responsible for ensuring that all site objectives for Safety, Health, and Environment (SHE) are met, maintaining a safe working environment.
• You will be responsible for reviewing batch production records, batch cleaning records, electronic batch production records (e-BPRs), and electronic batch control records (e-BCRs) for compliance and accuracy.
• You will be responsible for preparing and reviewing Process Performance Qualification (PPQ) protocols/reports, Continued Process Verification (CPV) protocols/reports, and Batch Production Records (BPRs) for existing products undergoing changes.
• You will be responsible for ensuring that trial recommendations are accurately captured in the validation batch production record for operational convenience and compliance.
• You will be responsible for adhering to established cGMP and safety protocols during all operations, reporting any deviations or incidents promptly.
• You will be responsible for reporting near-miss accidents to the appropriate Production Superior for investigation and corrective action.
• You will be responsible for documenting and reporting process/system deviations to Quality Assurance (QA), participating in investigations and implementing corrective actions as necessary.
• You will be responsible for executing and monitoring the commercialization of Critical Process Parameters (CPP) processes to ensure consistency and quality in production.
• You will be responsible for attending mandatory training classes on cGMP, SOPs, process, and operational safety to maintain compliance and competency.
• You will be responsible for verifying temperature tuning completion before starting up trials or validation batches to ensure process integrity and accuracy.