The Process Engineers function at the Rockville Biopharm site is to provide technical engineering and project management services for cGMP manufacturing operations including capital project management equipment optimization and tech transfer support. Motivated engineering professional who can manage small to medium projects while supporting manufacturing operations .

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

• Provide engineering support for the design testing and optimization of biopharmaceutical manufacturing equipment up to 20000L scale including stainless and single-use bioreactors centrifuges chromatography systems filtration skids pasteurizers chromatography skids etc.

• Manage capital projects and engineer solutions involving retrofits modifications and acquisition of process equipment.

• Support execution of technology transfer and scale-up activities.

• Lead resolution of technical issues with manufacturing operations and equipment.

• Collaborates with other manufacturing support groups including Validation Automation Quality Metrology Maintenance and Process Development.

• Applies knowledge of process and utility systems to make recommendations to improve manufacturing systems equipment and process efficiencies.

• Experience with project management (schedule cost communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.

• Subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment with ability to assist in the execution of design procurement testing (FAT SAT commissioning) installation and validation activities.

• Capable of negotiating contracts bids and change orders with vendors or contractors.

• Support investigations and recommend solutions with key stakeholders in order to gain a consensus on effective corrective and preventive actions (CAPA).

Why you

Basic qualifications:

• BS in Engineering or related technical discipline such as Biological Chemical Mechanical.

• 2 years of experience working in a regulated cGMP biopharmaceutical environment.

Preferred Qualifications:

• Experience with technical risk assessments and product control strategies.

• Capable of working in a collaborative and team focused environment.

• Demonstrated understanding of the product development process.

• Able to evaluate potential innovative technology areas relevant to products.

• Experience supporting batch and continuous industrial control systems.

• Change control and deviation management experience.

• Must be proficient with common business enterprise technologies including MS Office.

• Working knowledge of biopharmaceutical production quality systems and clinical or commercial manufacturing including cell culture and/or microbial processes.

• Demonstrated ability to participate as a member of a cross-functional team.

• Basic understanding and knowledge of biopharmaceutical production equipment including but not limited to bioreactors centrifuges CIP skids chromatography systems and filtration skids.

• Project management experience including the ability to manage a project by delivering scope cost and schedule.

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 purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your inquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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