Bioprocess Engineer - Biopharmaceutical Manufacturing Science

Site Name: USA - Maryland - Rockville Posted Date: Oct 20 2021 GSK currently has an opening for a Bioprocess Engineer in Rockville, MD. In this role you'll be part of the Biopharmaceuticals Technologies group supporting Biopharmaceutical in maintaining a Biopharmaceuticals process databases, files and hardware. You'll also provide support for data analysis and investigations. Key Responsibilities: Support campaign readiness activities to ensure success of upcoming campaign/ release of batches Lead cross functional meetings Batch record review, CAPA implementation Assisting with process investigations and data mining from a variety of sources, checking and conducting entry of data, running reports of in-process data trends, creating data visualizations, and designing data collection forms. Supporting analysis of data including statistical process control (SPC), multivariate analysis (MVA), and interpretation of results from lab experiments and commercial manufacturing (e.g. in-process trends, yield, productivity, and quality attributes). Assisting with authoring of technical process documentation including campaign reports, process change controls, and product impact assessments. Generating/updating technology transfer deliverables (e.g. process flow diagrams, bill of materials, sample plans, batch records). Providing support to determine adequacy of facility to accept new technologies through risk assessment, process modeling, and gap analysis activities. Driving appropriate actions to implement new technologies in facility. Providing process validation, continued process verification, and control strategy development support. Providing scale-up, tech transfer, and technical oversight support Updating of local procedures to optimize and align with global procedures As necessary will be required to carry out laboratory based biopharmaceutical process development/investigational activities. Design basic lab experiments and interpret data/results with supervision. Support After Action Reviews for different phases of campaign Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/BA degree in either biological or chemical science, engineering, Computer Sciences, Mathematics Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong interpersonal skills. Strong verbal and written communication skills. Strong critical thinking and problem-solving skills. Able to prioritize and decide appropriate courses of actions. Effective at implementing decisions. Committed team player prepared to work in and embrace a team-based culture. Working knowledge of database management systems preferred. Knowledge of spreadsheets and data analysis software preferred. Experience in use and developing of databases will be a plus. 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.