Site Name: USA - Pennsylvania - Marietta Posted Date: Dec 19 2024 Are you looking for a more technical role, where you can directly develop, validate, optimize, and maintain robust manufacturing processes? If so, this Senior Process and Validation Specialist/Process and Validation Specialist role could be an exciting opportunity to explore. As a Senior Process and Validation Specialist/Process and Validation Specialist, you will focus on supporting process efficiency, consistency, and compliance with regulatory and quality standards which involves new product introduction, technical transfers, validation lifecycle, troubleshooting, continuous improvement initiatives, and cross-functional collaboration to support the production of high-quality, safe and cost effective vaccines in line with Site, GSK, and Regulatory requirements, especially in some of the following areas: vaccine’s raw materials, buffer preparation, single use system, homogenization, complexation, formulation, filtration, aseptic filling, automated visual inspection and/or testing. This role is essential for ensuring that manufacturing processes and products comply with standards and meet quality requirements. This position focuses on planning, executing, and documenting activities to ensure the consistent production of safe and effective vaccines. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Process Provide support to design, tech transfer, validate, and monitor manufacturing and cleaning processes to ensure optimal performance in your area of expertise Analyze process data and trends to identify opportunities for improvement and reduce variability. Support continued process and cleaning verification (CPV/CV) by tracking critical process parameters (CPPs) and process efficiency through monitoring of manufacturing process parameters (MPPs) Support process/product-related improvement programs resulting from Quality, Safety and yield activities. Stakeholder Management Establish key relationships within the site across Operations, MSAT, Quality, Engineering and EHS. Collaborate with multidisciplinary local teams to balance compliance, cost, and supply risks to arrive at effective and practical solutions Training and Development Support your peers to ensure other functions have sufficient knowledge in your area of expertise to execute their roles effectively. Support the development of standardized training materials with regards to your area of expertise and provide training as required. Root Cause Analysis, Continuous Improvement and Support Support the operating units to enable routine day-to-day manufacture and resolve technical issues within your scope of expertise. Support investigations relating to manufacturing issues, product, process and cleaning performance, and customer complaints using effective deviation management techniques. Support process optimization and continuous improvement opportunities using GPS and PLM systems and tools. Compliance and Audits: Provide necessary support with regards to your area of expertise for all levels of corporate, customer, and regulatory audits. Support compliance with regulatory requirements and GSK standards. Support the deployment of the standards with respect to your area of expertise to meet business needs. Validation Support the validation and lifecycle maintenance of process and cleaning, to support site objectives. Develop and provide your expertise, ensuring compliance with cGMP. Participate in the provision of local Periodic Product Reviews and Validation Plans. Support the development of standard validation processes and roll-out and adherence to these processes. Other Ensure that EHS, Sustainability and GPS are supported. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s Degree Minimum of 2 years in vaccine pharmaceutical process and/or validation experience, preferably a multinational one. Preferred Qualifications: If you have the following characteristics, it would be a plus: Knowledge and understanding of vaccine’s raw materials, single use system, filtration, homogeneity, complexation, buffer preparation, formulation, aseptic filling, automated visual inspection and/or testing. Experience with investigational techniques, tools for process investigations and trouble shootings. We are also looking for more experienced individuals for our Senior Process and Validation Specialist 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: Bachelor’s Degree Minimum of 5 years in vaccine pharmaceutical process and/or validation experience, preferably a multinational one. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree or PhD Knowledge and understanding of vaccine’s raw materials, single use system, filtration, homogeneity, complexation, buffer preparation, formulation, aseptic filling, automated visual inspection and/or testing. Experience with investigational techniques, tools for process investigations and trouble shootings. Excellent technical writing and oral communication skills. Ability to navigate critical business systems and databases (e.g., MERP, IP21) and mine relevant data for reporting, review, and analysis. Statistical knowledge to assess/interpret statistical data (e.g. process capability, control charts, DoE, MSA) and use of Statistica, JMP, SAS, PBI or other data analysis software Familiar with risk-based approaches and use of data to design process evaluation, design of experiments and process performance qualification strategies. In-depth Knowledge of cGMP and related guidelines (specifically ICHQ8-11) and good understanding EHS requirements. Ability to contribute to and effectively influence matrix teams, colleagues and peers in other functions. Basic understanding of the drug development process. Demonstrated ability to manage projects to completion on time and within budget Ability to adapt to a changing environment and regulatory requirements. High personal integrity and the ability to work independently or within a project team #LI-GSK #mariettavaccines #globalsupplychain Please visit GSK US Benefits Summary to 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 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. 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