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Process Development: Process/Systems Engineer

Collegeville, Pennsylvania
Closing date
Aug 5, 2021

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Science, Physical Sciences and Engineering, Pharmaceutical, Supply Chain, Quality Assurance
Jobseeker Type
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Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Jun 25 2021 GSK is seeking a Process/Systems Engineer to support a variety of projects. This position can be based out of either our site in Collegeville, PA, USA or Stevenage, UK.. Key Responsibilities: Work collaboratively with C> scientific leads, process/analytical development scientists, QC, Operations, R&D Tech and CMC to ensure delivery of robust, capable, efficient, scalable, validatable manufacturing processes and information systems for production and research use. Ensure the health, safety and environmental performance of our manufacturing processes Contribute to the definition and delivery of development/manufacturing programmes outsourced to external Contract Manufacturing Organisations Propose, define, develop and validate innovative manufacturing, systems and automation technologies and approaches to make step changes in manufacturability of cell-gene therapy products Maintain awareness of new, emerging technologies and competitor process/system technology/manufacturing activity Project management to facilitate interactions with internal groups, external collaborators and partners. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BSc or five years of related experience in Chemical Engineering, Biochemical Engineering, Materials Engineering, Information systems or other related engineering disciplines 2 years of experience in the development and manufacture of biotherapeutics, medical devices, related supporting systems or cell therapy products Experience with process development using principles of design for manufacturability, Quality by Design (QbD) in the biotherapeutics or medical device or cell therapy industries Experience of manufacturing using single use systems Experience in the use of statistical experimental design, data analysis, systems architecture and development of highly capable manufacturing processes Experience working closely with process development scientists to establish efficient clinical and commercial manufacturing processes. Preferred Qualifications: If you have the following characteristics, it would be a plus: MSc and/or PhD in Chemical Engineering, Biochemical Engineering, Materials Engineering, Information Systems or other related engineering discipline Experience of virus manufacturing Excellent communication and project management skills to facilitate interactions with internal groups, external collaborators and partners. Experience of technology transfer, establishment, qualification in GMP biopharmaceutical industry setting 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, rigour 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 *LI-GSK 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. 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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