GSK is currently looking for a Process Engineer to join our team. The 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. Motivated engineering professional who can manage small to medium projects while supporting manufacturing operations.
- 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).
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Engineering or equivalent technical discipline
- Minimum of 2 years’ experience working in a regulated cGMP biopharmaceutical environment.
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 crossfunctional 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.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.