To be responsible to Formulate, submit for approval, execute and evaluate validation protocols, capability studies and engineering tests for all new or renovated production and process equipment and facilities within Singapore Manufacturing.
To be responsible to Supervise the operation of plant utility systems and provide technical expertise to maintain these systems and the major production equipment throughout the plant facility.
To Operate an effective, GMP-compliant maintenance function, minimizing equipment downtime to the extent possible while ensuring system and equipment quality specifications are consistently met.
To Serve as the lead for installing new or upgraded production and plant utility equipment and ensuring the associated maintenance requirements are established and performed.
To Provide training and oversight to department staff in order to execute and document responsibilities in a complete manner per SOP requirements.
To Provide investigation support to QMS events with respect to the required analysis for technical, plant utilities, and cleanroom facilities.
To Maintain inspection readiness for facility, plant utilities and systems at all times.
To Drive implementation of company -wide improvement projects for achieving enhanced and sustainable GMP site wide compliance with manufacturing equipment and plant utilities.
To Track and ensure completion of regulatory commitments associated with Technical and Utility department projects or operations.
To Maintain complete and accurate departmental SOPs at all times. Ensure all required department tasks and responsibilities are addressed and resolved.
To Perform technology upgrades for older machines, systems to comply with the newer regulations, audit findings, and GMPs.
To Ensure consistent, quality utility output and continuous monitoring in support of sterile manufacturing operations.
To Ensure that downtime, periodic sanitization, replacement, etc., are managed adequately to keep up with the peak needs for sustained manufacturing.
To Maintain adequate cleanroom facilities (including doors, panels, gaskets, flooring, personnel airlocks, material transfer hatches, classified rooms, etc.), instrumentation, and electrical/mechanical systems while seeking continuous improvement for quality and GMP compliance in support of sterile product manufacturing.
To Install and commission new process equipment and systems to improve facility capacity, reduce costs and minimize bottlenecks.
To Provide proactive technical expertise in all aspects of technology, facility, utility, and instrumentation in support of business operations.
To Support manufacturing operations with adequate facility modifications to improve workflow and enhance compliance.
To Escalate BMs to Overall Head Technical and Utility and Quality management in case of critical failure which may compromise purity, efficacy, potency and safety of drug product and track it through the CAPAs.
To Lead engineering and technical resources in support of required Site Acceptance Testing (SAT) for new manufacturing equipment or plant utilities for the facility.
To Review equipment performance monthly per defined productivity norms. Apply continuous improvements.
To Initiate, investigate, show CAPA effectiveness, and bring to closure QMS Records associated with Technical and Utility department operations.
Overall 15+ years experience in domains like Pharmaceuticals Sterile Formulation in USFDA approved facility.
Good Knowledge of Global practices with respect to Engineering.
BE Mechanical/ Electrical
Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.
Claris Lifesciences is an Indian sterile injectables pharmaceutical company with a... market presence across 100 countries worldwide. We primarily manufacture and market products across multiple markets, and therapeutic segments. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses. Read full description