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Senior Manufacturing Engineer

Employer
GSK
Location
Gaithersburg, MD
Closing date
Dec 8, 2021

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The Senior Manufacturing Engineer 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. Assist in leading 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. Demonstrated project management skills (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 demonstrated ability to lead execution of design, procurement, testing (FAT, SAT, commissioning), installation and validation activities. Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in Engineering or equivalent technical discipline At least 5 years of relevant experience working in a regulated cGMP biopharmaceutical environment. Preferred Qualifications: If you have the following characteristics, it would be a plus: 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. Advanced 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. In-depth 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. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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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