Process Engineer

2 months ago

Rockville, Maryland, United States GlaxoSmithKline Full time
Site Name: USA - Maryland - Rockville
Posted Date: Jul

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.

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 or related field (i.e. biological, chemical, or mechanical)
  • Minimum of 2 years' experience working in a regulated cGMP biopharmaceutical environment.


We are also looking for more experienced individuals for our Senior Process Engineer role. The qualifications for this role at our site are listed out below:

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)
  • 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

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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