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Lead Process

4 months ago

Emory, United States ABBVIE OPERATIONS SINGAPORE PTE. LTD. Full time

Roles & Responsibilities Purpose Statement:

Responsible for design, operation and optimization of chemical / biologic processes. Coordinate and deliver projects actively leading the integration of technical activities with operations including providing technical support to ongoing operations. Analyze new processes and evaluate them to assess needs and feasibility of introduction of these processes into the existing facility.

Responsibilities:

Responsible for design, operation, control and optimization of chemical / biological processes.

To drive the commissioning and qualification effort of the process equipment and associated systems.

Design, install and commission new production units, monitoring modifications and upgrades and troubleshooting existing processes.

Improve process capability and production volume while maintaining and improving quality standards.

In a cGMP environment, lead modifications and changes to processes and equipment, troubleshooting, deviation investigation, identification and completion of corrective and preventative actions.

Propose and evaluate modifications to equipment, processes and operations to improve safety, increase efficiency and enhance company goals.

Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs and changeovers.

To actively seek avenues to improve operational efficiency accruing benefits to the Abbvie businesses in Singapore.

Actively engaged in developing specifications for process equipment and assist in FAT / SAT of related equipment as part of the new build-outs.

Participate and lead, when required, in all investigations (contaminations, deviations, and discrepancies) relating to the manufacturing process.

Develop and implement systems that ensure the process works at the optimum level, to the right rate and quality of output, in order to meet supply needs.

Provide operational support for the successful and uninterrupted operation of manufacturing systems used in manufacture of API and biologic products.

Act as one of the key contact points and local SME for investigations into utility excursions and deviations and provides resources to ensure fixes.

Supervise engineers and provide day to day guidance on technical issues.

To mentor and coach reports.

Identify equipment and assess plant production capacity.

Identify means to resolve equipment bottlenecks & optimize production capacity.

Basic Qualifications: Bachelor’s degree or a diploma in Engineering. At least 9 years of relevant work experience.

Preferred Qualifications: Knowledge of cGMP is highly preferred. Strong technical knowledge coupled with hands-on working experience in a pharmaceutical / biotech facility. Working experience in start-ups, commissioning & qualification of process systems in an operating plant is a plus. Excellent leadership and communication skills. Ability to lead teams including external contractors. Excellent team player willing to work for the common goal. Mentoring and coaching skills.

Skills:

Troubleshooting, cGMP Manufacturing, HAZOP, Process Capability, GMP environment, Investigation, FDA, GMP, Electrical, Construction Safety, Process Engineering, Engineering Design, Systems Design, Instrumentation, API, FEED Manufacturing, Electronics, Commissioning

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