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Principal Process Validation Engineer

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Company :
Adaptimmune Ltd

Location :
Philadelphia, Pennsylvania

Expiry Date :
Mon, 14 Dec 2020 23:59:59 GMT

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Description :
Primary Responsibility The Principal Process Validation Engineer will lead lifecycle activities associated with the production of personalized cell therapy products. The Principal Process Validation Engineer leads the development of qualification/validation documents (e.g. protocols and reports) satisfying internal and external regulatory expectations. He/she oversees the development and execution of lifecycle activities in support of Adaptimmune’s T-cell product portfolio. Key Responsibilities Manage the execution of process validation activities including designing protocols and studies, evaluating process and assay data, investigating protocol deviations and acceptance criteria failures, and compiling final summary reports. Support the implementation of process control strategies by collaborating with Process Development, Manufacturing Science and Technology, and Process Engineering. Ensure control strategy content is developed to facilitate regulatory submissions including IND, IMPD, MAA, and BLA. Review and maintain the content of technical lifecycle documentation (i.e. QTPP, Process Parameter reports, Material Attribute reports, Control Strategy Documents, etc) ensuring compliance with the validated state of the process. Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state of the process. Apply risk management tools and principles throughout the process validation lifecycle. Support technical transfer projects and continuous improvements at contractor manufacturing organizations for the manufacture of Adaptimmune products. Participate in efforts to identify opportunities for and to implement continuous improvement of practices related to validation. Manage analysis of manufacturing data and support development of database for the collection, control,and access of key process and development data. Support the development of process monitoring systems, and implementation of statistical process control. Maintain inspection readiness and actively support regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors. Stay current with industry trends and standards (PDA, ISPE) and participate in best practice forums consistent with function responsibilities. Participate in routine plant operating meetings and serve as Validation SME. Qualifications & Experience Required Bachelor’s degree required (Science or Engineering preferred). Significant years of manufacturing support or related experience in the biopharmaceutical industry. Expert Knowledge of cGMP’s, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations. Strong understanding of the application of a lifecycle approach (process design, process qualification, and continued process verification). Strong knowledge of Quality Risk Management and experience with performing risk assessments using a variety of tools, i.e. FMEA. Must be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks. Must possess strong verbal/written communication skills and ability to influence at all levels. Experience utilizing quality systems to support process validation activities (document management, training, Incident/Deviation management, Change Control management, and CAPA). Desirable Master’s degree (Science or Engineering preferred). 8 or more years of manufacturing support or related experience in the biopharmaceutical industry. Experience with leading the start-up, validation, and licensure of manufacturing facilities. Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process validation). Experience working with cell and gene therapies or biologics products. Experience working with external parties and/or leading cross-functional teams. Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies. Skills & Competencies Required Deep knowledge of facility/clean room design, process, equipment, automation, and validation. Ability to think strategically and to translate strategy into actions. Must be able to prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment. Ability to provide clear direction to team members in a highly dynamic environment Candidate must be proficient in Microsoft Word, Excel, PowerPoint. Desirable Experience with Operational Excellence and Lean Manufacturing. Lean Six Sigma Green Belt certification from an accredited institution (i.e. ASQ). Proficient with the use of statistical analysis software (i.e. JMP, Minitab) decision making authority The primary decision-making authority is related to lifecycle/validation activities with guidance from the Process Validation Lead. Additional leadership and behavioural expectations for the role include the following: Create an environment of teamwork, open communication, and a sense of urgency. Support the change agent in promoting creativity and accountability. Support organizational strategic goals and objectives that are linked to the overall company strategy. Drive strong collaboration within the plant and across the network. Build trust and effective relationships with peers and stakeholders. Foster a culture of compliance. Promote a mindset of continuous improvement, problem solving, and prevention. other requirements The primary work location is in the Philadelphia site. Travel is not expected initially for the role. Domestic and International travel may be required to provide oversight of Process Validation activities at CMOs or at Adaptimmune’s facilities in the UK. (