Validation Engineer

Penn Life Sciences-posted 8 months ago
Full-time • Entry Level
Langhorne, PA
11-50 employees
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Penn Life Sciences is looking for a Validation Engineer to join our team in Langhorne PA. In this role, you will support site commissioning and qualification, which includes but is not limited to the following: equipment, utilities, cleaning, process, assay qualifications. Ensuring the timely development, execution, and coordination of all validation activities pertaining to facility, equipment, and process in compliance with Quality System requirements, site procedures and regulatory requirements. This role will develop validation and Quality System documentation (e.g., IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize all validation activities ensuring project completion per schedule requirements.

  • Maintain the Company's compliance with established PLS Standard Operating Procedures and specifications and Current Good Manufacturing Practices.
  • Write, execute and coordinate commissioning, qualification and validation protocol testing.
  • Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies.
  • Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations.
  • Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements.
  • Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes.
  • Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training.
  • Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies.
  • Ability to manage and plan multiple projects.
  • Knowledge of cGMP's, GDP's and regulatory requirements as they related to qualification and validation activities (IQ/OQ/PQ).
  • Possess a working knowledge of Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/Jmp.
  • Must possess excellent analytical skills, good problem-solving technique and data analysis skills using Excel.
  • 401(k) with matching
  • Health, Vision, Dental Insurance
  • Childcare Scholarship
  • Tuition Reimbursement
  • Bonus Pay + Merit Increases
  • Paid Time Off
  • Flexible Holidays
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