GSK is currently looking for a Sr. Process Engineer to join our team in Rockville, MD. The Senior Process Engineer’s 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. Experienced and motivated professional who can manage medium to large projects while supporting manufacturing operations with minimal supervision

Key Responsibilities:

• Provide engineering support for the design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L 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:

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

• BS Degree in Engineering
• Minimum of 5 years’ experience working in a regulated cGMP biopharmaceutical environment.  

Preferred Qualifications:

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

• 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
• 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 including Delta V.  Change control and deviation management experience.
• Must be proficient with common business enterprise technologies including MS Office systems and filtration skids.
• Project management experience, including the ability to manage a project by delivering scope, cost and schedule.

#LI-GSK

The annual base salary for new hires in this position ranges from $120,615 to $163,185 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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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