Sr Process Validation Engineer
Social Circle, Georgia
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Sr Process Validation EngineerApply Now
Effectively contribute to manufacturing support by leading the execution of process validations necessary for the implementation of process changes including new product introduction and improvements of existing commercial processes. This role will assist in the execution of the Site’s process validation program by providing in-depth scientific understanding of large-scale protein purification.
With minimal oversight, an employee in this role will:
- Review and assess process changes for impact to current validated state
- Analyze process validation deviations and document analysis and justifications/conclusions
- Review and assess changes to process documentation
- Define Site process validation strategy from a protein biochemistry perspective
- Appliy thorough understanding of cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
- Perform a variety of projects/studies in areas that may include Product/Process, sterilization, as well as projects/studies to support manufacturing.
- Handle projects that are more complex and broad in scope, such projects require team leadership, task prioritization, and management of budget and/or time constraints. Must demonstrate competent and effective planning, coordination, and organizational skills.
- Author and review protocols, reports, Change Controls, Regulatory submission content.
Conduct Studies and Execute protocols
- Without assistance, make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
- Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes.
- Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to technical operations (product development, design and safety) to ensure compliance in all development, data collection and reporting activities.
- Recommend appropriate designs, techniques and processes for a specified sequence of tasks where needed. Contribute to technical feasibility analysis of complex research and design concepts
- Monitor budgets and/or activity schedules of limited scope.
- Minimum of a Bachelor's degree, preferably in Engineering, Molecular Biology, Chemistry or Biochemistry plus a minimum of 5 years pharmaceutical industry experience required. Advanced degree (MS and/or PhD) in similar disciplines plus 0 to 5 years industry experience preferred.
- Education in the use of statistics for data analysis; the ideal candidate will have experience using Minitab, SIMCA or similar software
- Direct experience in bioprocess; the ideal candidate will have experience in protein processing and purification
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Job ID SR0045131