Senior validation engineer

Digital Intelligence Systems, LLC in Miami, FL

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
  • Compensation: $72,100.00 - 113,600.00 / Year*
position filled
Role Senior Validation Engineer Location Miami, FL Duration Long Term. Experience Minimum of 8 years of validation experience in Pharmaceutical Biotechnology industry. Experience with aseptic processing systems and sterilization processes preferred. Experienced in new product introductions, technical process and method transfers. Project management experience and the ability to organize and manage projects and coordinate the efforts of multiple groups within different companies divisions. Ability to influence without authority to achieve project objectives. Knowledge, Skills, Abilities Thorough knowledge of quality management systems and validation principles for manufacturing processes and laboratory test methodologies, engineering design fundamentals, regulatory agency expectations, and industry trends. Hands-on experience in validation protocol generation and execution for equipment, computer systems, and analytical methods. Capable of independently applying validation principles to projects, review and approval of documents, and problem resolution. Knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications. Sufficient knowledge of chemistry, microbiology, and other sciences to effectively meet the responsibilities of the position. Possesses technical and analytical skills to be able to lead root cause investigations in a timely and effective manner. Strong technical writing, effective verbal communication, and interpersonal skills. Ability to prioritize and perform multiple tasks, with minimal supervision required. Ability to work in teams to obtain results, self-motivated, and ability to effectively manage conflict. Working competency of Microsoft Word, Excel, Power Point, Project, and statistical programs. Certified Six Sigma Green Belt or equivalent preferred. Must be flexible to meet requirements of qualification work schedules.PandoLogic. Category: Quality Control, Keywords: Quality Control / Quality Assurance Engineer
Associated topics: biomechanics, biomedical engineer, biophysics, biosynthetic, metabolic, neuro, neurodegenerative, neuroscience, parenteral, pharmaceutical

* Estimated salary


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