Process Engineer II

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The Production Process Engineer II is responsible for supporting and maintaining all large-scale USP/DSP (Upstream Production / Downstream Production) equipment and instruments to ensure the manufacturing process is continuously in operation with minimal downtime. Through process mapping and understanding, the process engineer II is responsible for developing process improvement projects, performing engineering design evaluations, creating efficiency in the USP/DSP process, and improving quality of product.

The process engineer will not only account for identifying and researching background for equipment purchases and making recommendations to management. In addition will play a key role working with third party contractors to ensure the process IQ/OQ/PQ on a timely manner The independently troubleshooting capability is required.

Maintain all USP/DSP equipment and instruments at the ready-to-run status to ensure that manufacturing is continuously in operation with minimal downtime.

When needed, be responsible for design, installation, and qualification of batch processing tanks, solvent recovery system, filter dryers, filtration system, ultra low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and waste water system.

Ability to learn the automation system trouble shooting including a programed recipe fixing, changing and testing.

Support production on CAPEX projects for production facility and equipment improvements in order to increase production efficiency and reduce cost.

Perform activities associated with the design and qualification of the new and existing USP/DSP equipment used in a manufacturing plant.

Support large-scale production process development and optimization projects.

Provide technical guidance and support investigations for process related deviations, change control and operational excellence projects.

Oversee implementation, commissioning, and qualification of USP/DSP facility and process equipment.

Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error.

Maintain a safety first approach in the large-scale manufacturing workplace.

Communicate operational status regularly to senior management and corporate management, as required and appropriate. Communications include written documents and formal / informal oral presentations.

Maintain a high level of compliance and efficiency to drive the organization to world-class manufacturing standards.

Create new process and equipment drawings to existing processes based on specifications and standards.

Update and maintain drawings and P& reflect changes to existing processes.

Responsible for trouble shooting and providing corrective action directives.

Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities.

Create, execute validation protocols and write validation summary reports.

Draft of new procedures, SOP’s and protocols as well as training of staff for these expectations.

Write technical reports to support the process development data.

Write standard operations procedures, standard test procedures, master batch records, and other related GMP documents.

Bachelor's Degree BS degree in Mechanical, Electrical, Chemical, Manufacturing Engineering.

Master's Degree MS degree in Mechanical, Electrical, Chemical, Manufacturing Engineering (Preferred).

Minimum 5 years of experience of pharmaceutical engineering and/or manufacturing.

Thorough understanding of engineering fundamentals.

Deep knowledge of cGMP, pharmaceutical manufacturing facility, large-scale equipment, and engineering principles.

Good understanding of computer programming and software development.

Ability to troubleshoot equipment problems and perform complex system tests.

Technical knowledge of USP/DSP processes / equipment / automation / utilities (e.g. large-scale chemical reactor, cleavage vessel, deprotection vessel, solvent delivery system, agitator, batches processing, tank, filtration, purified water system, hear exchanger, HVAC, etc.).

Equipment Qualification and Validation IQ /OQ / PQ and SOPs.

Excellent written and oral communication skills.

Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues.

Ability to work independently and manage one’s time.

Ability to schedule and host internal/external meetings and negotiate with vendors, contractors, and customers for the best interest of the production department. Excellent computer knowledge, including Microsoft Word and Excel.

Communicate effectively and ability to function well in a team environment.

Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.

Detail oriented with the ability to troubleshoot and resolve equipment and process problems and deviations.

Strong…