- Perform engineering assessments to identify and address process issues (scale-up, safety, equipment selection, etc.) related to the introduction of new processes, equipment, or technologies into the pilot plant.
- Identify and facilitate the introduction of new equipment or technologies into the pilot plant; this includes development and implementation of change controls, user requirements, commissioning documents, and engineering studies for both GMP and non-GMP process equipment and utilities.
- Coordinate and provide technical support for the GMP and non-GMP process equipment (sterilizers, ovens, fill line, VHP decontamination system, mills, etc.) and critical utilities (HVAC, purified water systems, clean compressed air, clean steam etc.). Interface with front line maintenance support staff to coordinate and provide technical support for the process equipment and utility Preventative Maintenance (PM) programs within both the Sterile's clinical and development lab facilities.
- Provide oversight to the Sterile facility's incursion program which involves the monitoring and alarming of critical environmental and utility parameters via the facility's distributed control system (DCS).
- Provide engineering support for quality or safety related risk assessments [e.g. Process Hazard Assessments (PHA) / Hazard Operability (HAZOP) studies], gap assessment against corporate standards, and deviation investigations and their associated corrective and preventative actions (CAPA).
- Provide engineering and sterile operations expertise for capital projects, including scope development, user requirements, and liaison between project team and management. Ensure project outcome meets the business needs of Sterile Manufacturing while being completed on time and on budget.
- BS in Chemical or Mechanical Engineering with 2 + years steriles or biopharmaceutical processing experience
- Experience with validating equipment within a GMP environment.
- Automation control experience with DCS systems.
- Effective oral and written communication skills and the ability to work within a collaborative environment.
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Process Engineer - King of Prussia, United States - GlaxoSmithKline
Description
Site Name: Upper MerionPosted Date: May 3 2024
Are you energized by the challenge of designing innovative ways to use Process Engineering to develop medicines for patients? If so, this Process Engineering opportunity could be an exciting opportunity to consider. The Process Engineering Team within the Upper Merion, Steriles Pilot Plant delivers technical and engineering expertise to support the manufacture of Sterile drug product used for development and clinical trials. These engineers are responsible for providing support for the introduction of new processes, equipment or technologies into the pilot plant along with maintaining the equipment and facilities. We are seeking an introductory level engineer to deliver the technical knowledge and engineering expertise to support the scale-up, transfer, and manufacture of Sterile fill processes and manage pilot plant equipment and facility infrastructure.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
# LI-GSK
Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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