Validation Engineer I

Endo International-posted 3 months ago
Full-time • Entry Level
Rochester, MI
Chemical Manufacturing
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The Validation Engineer I evaluates and performs specified validations leading to the accurate and reliable validation of products, processes, equipment, facilities, and systems; assists/performs development of studies/cycles for new processes; helps troubleshoot product problems related to validation; performs testing and documents results for review by site, corporate and government review. Further responsible for providing supporting protocol rationales/justifications for the chosen validation methodology/approach. Participates in programs to achieve departmental objectives. Records and reports results. Notes unusual results and notifies management for evaluation. Assists with writing validation documents. In partnership with the site leaders, sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

  • Generates validation protocols, and summarizes studies to ensure consistency of data production and compliance with manufacturer and Par Sterile Product's specifications, with current Good Manufacturing Practices, and national standards.
  • Responsible for confirming all communicated validation plans to applicable management.
  • Provides technical assistance in the form of rationales or validation studies to support acceptability of the manufacture of products at Par Sterile Products.
  • Assists with development of validation protocols, performs testing and writes validation reports for various equipment/processes pertaining to the manufacturing area.
  • Helps to determine process capability of new equipment through execution of approved protocols and assures that defined parameters are incorporated into respective operating procedures.
  • Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.
  • Troubleshoots and resolves issues as needed.
  • Responsible for the performance qualification of production processes, and writes process validation protocols and final report packages.
  • Generates, executes and summarizes Product Process Qualification for the entire scope of the production processes.
  • Provides validation input at team meetings for various projects.
  • Capable of managing multiple projects while adhering to project deadlines.
  • Conducts deviation investigations.
  • Evaluates equipment or process problems and designs testing to determine possible causes or solutions.
  • Establish and maintain effective cross functional relationships.
  • Bachelor of Science in Engineering or Science discipline preferred.
  • Zero (0) to three (3) years of combined experience in pharmaceutical (i.e. Validation/QA or R D), medical device, biotechnology industries or equivalent combination of education and experience.
  • Proficiency in knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
  • Proficient in Microsoft Word, Excel, Power Point, Project and other software relevant to the performance of the Job.
  • Problem Solving - Identifies and resolves problems in a timely manner.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations.
  • Written Communication - Writes clearly and informatively.
  • Teamwork - Balances team and individual responsibilities.
  • Diversity - Demonstrates knowledge of EEO policy.
  • Ethics - Treats people with respect and keeps commitments.
  • Professionalism - Approaches others in a tactful manner.
  • Quality - Demonstrates accuracy and thoroughness.
  • Safety and Security - Observes safety and security procedures.
  • Attendance/Punctuality - Is consistently at work and on time.
  • Dependability - Follows instructions and responds to management direction.
  • Initiative - Volunteers readily and seeks increased responsibilities.
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