Are you energized by an engineering role that enhances your leadership capabilities and allows you to shape process improvement across the site? If so, this Process Engineer role could be an exciting opportunity to explore.

As a Process Engineer, (Oral Solid Dose) you will provide support of technical and scientific activities including implementation of Product Control Strategies, technology transfer, product investigations, change management, and continuous improvement projects.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Support technical change activities relating to new and existing products, processes and materials (transfers, qualifications and optimization activities) utilizing Change Control Procedures.  Support multiple process engineering projects and process validation initiatives.

• Manage Product Lifecycle Management/Continued Process Verification activities through effective data management activities (gather, analyze and trend).

• Support investigations relating to manufacturing issues, product release performance and or customer complaints using effective deviation management techniques to help drive towards the identification of true root cause, identify golden CAPAs, and mitigate risk of repeat deviations.

• Support Continual Improvement activities by identifying projects using the both the GPS and PLM system and tools to improve yield, improve OEE/efficiency, reduce cost of poor quality, and reduce cost of goods.

• Create documents including Batch Documentation, Validation Protocols, Evaluation Protocols/Reports, Investigation Reports and SOPs. 

• Interact with internal and external auditors and regulatory agencies as needed during inspections. Provide support and review of Regulatory Documents.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS Degree in Engineering or related field (i.e. biological, chemical, or mechanical)

• Experience working in a regulated cGMP biopharmaceutical environment.  

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Knowledgeable in cGMP’s and regulatory requirements.

• Strong written and verbal communication skills.

• Working knowledge of pharmaceutical equipment and processes.

• Experienced with the investigational techniques and tools for process investigations and Technical Risk Assessment.

• Knowledgeable in the principles of cleaning validation, process validation and packaging validation.

• Proficient with Microsoft Project, Word and Excel.

• Statistical knowledge and use of Statistica, JMP, SAS or other data analysis software.

• Demonstrate Teamwork in being able to actively participate in project teams to execute project goals and assignments.

#LI-GSK

Please visit  GSK US Benefits Summary to 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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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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