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Validation Engineer

Company: TRC Staffing Services
Location: Athens
Posted on: June 13, 2021

Job Description:


The Validation Engineer is responsible for supporting existing commercial operations and new business projects within a multifunctional team environment, which includes the manufacture and packaging of Rx, OTC, Medical Devices, Powders, Cosmetics and Consumer Disposables.



Responsibilities:

  • Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function
  • Support the development and transfer of new and current products from clients into the manufacturing environment. This includes feasibility studies, scale-up, pre-validation development, validation, and post-validation evaluations such as trending of CQAs.
  • Apply the principles of Process Validation as per current FDA / ICH guidance for 3-stage Product Lifecycle Management (PLM)
  • Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish acceptance criteria and identify and implement solutions to meet PTI s requirements.
  • When required, assists with preparation of regulatory filings, with answering questions from customers and regulatory agencies, and with presentations of materials during regulatory inspections/customer audits.
  • Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
  • Determine methods and procedures on new assignments independently and in accordance with developed practices and procedures.
  • Perform Technical Risk Assessments and develop appropriate mitigation plans for higher level risks as requested
  • Identify problems through trend and investigational data and conduct/lead problem solving using root cause analysis; provide technical impact assessment as required for QA to disposition impacted product
  • Ensures all work is performed and documented according to approved standard operating procedures, and in compliance with cGMPs and GDPs. Accomplish deliverables as requested by clients and project management as per agreed schedule. Escalate issues as soon as evident to management and develop mitigation actions
  • All other activities commensurate with the role, as requires.

Qualifications:
  • Bachelors or equivalent degree in Engineering, Scientific, or related technical field is required
  • A minimum of five (5) years of technical experience supporting a pharmaceutical or similarly regulated environment supporting commercial manufacturing or product development is required.
  • Direct experience in process in Process Validation is required.

Please send resume to andy.Youmans@trcstaffing.Com



About TRC Professional Solutions

For over 10 years, professionals and employers have trusted TRC Professional Solutions with their business and careers. Year after year, Inavero s Best of Talent and Staffing awards have been presented to TRC Professional Solutions for providing superior service and results to both our clients and job seekers. We create a different experience for our candidates and clients by remaining solely focused on bringing the right talent to the right opportunity, throughout every stage of our unique recruitment process. For more information, visit: https://www.Trcprofessionalsolutions.Com/



Although the emergence and progression of COVID-19 has changed our personal and professional routines, TRC is actively recruiting, interviewing, and placing candidates for all manner of positions. For information on applying, or your current application status, please contact your branch location via email, phone, or the TRC candidate portal.



TRC Staffing Services, Inc. Is an Equal Opportunity Employer and considers all qualified candidates for employment without regard to race, color, religion, gender, gender identification, sexual orientation, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: TRC Staffing Services, Athens , Validation Engineer, Other , Athens, Georgia

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