Validation Engineer

Full Time
USA
Posted 8 months ago

No of Positions: 1

Location: Austin, Texas, USA

Job Description: Pharma Tek Solutions is currently looking to hire Validation Engineer will 1-2 years of relevant experience in Biotechnology or closely related field, and is required to perform the following duties:

  • Use expertise in medical device Quality Management System regulations and standards including ISO 13485 and 21 CFR 820, and failure analysis techniques such as 5 WHYs, Failure mode and effect analysis & fishbone diagrams to lead investigations or non-conformities (NC’s) found during quality assurance and manufacturing testing.
  • Use foundational knowledge of biology and engineering principles to troubleshoot issues, document investigation reports, design of experiments (DoE), and data analysis as part of the investigation process.
  • Perform process capability studies to measure the process ability to produce parts within required specifications.
  • Implement integrated control charting within semi-/automated production equipment to ensure the validated manufacturing processes and systems remain in a state of control (e.g. Continued Process Verification). Use data analysis skills to perform trending and tracking of data to identify and mitigate potential failures using statistical process trending via Minitab (Run charts, Box plots, Histograms, control charts).
  • Lead and assist in investigating and resolving findings impacting the Operations organization identified through audits, corrective/preventative actions, or customer complaint escalation related to semi-/automation reagent production processes/methods.
  • Perform cost/benefit analysis for product/process improvement projects and enhance manufacturing processes, cleaning processes, and product specifications through Lean Six Sigma methodologies. Implement standard work and lean processes (Kaizen, 5S, Gemba) to achieve more efficiency.
  • Design and plan protocols for equipment or processes to produce new or enhanced versions of existing products adhering to FDA, GMP, and GLP requirements.
  • Ensure new products/ processes are safe and environmentally friendly by reviewing their design and test results before they are implemented into production.
  • Develop and design the risk management plans for new projects transitioning into manufacturing such as Hazard assessment, design trace matrix development, DV&V testing, and FMEA (DFMEA, PFMEA, UFMEA) using thorough knowledge and understanding of ISO 14971 and risk management practices.
  • Implement DMAIC (Define, Measure Analyze, Improve, and Control) methodology for problem-solving and root-cause analysis (RCA).
  • Develop, validate, implement, and support software/firmware programming for semi-/automation processes/methods. Collaborate with R&D on Operational Qualification (OQ) process validation planning and execution.
  • Lead and assist in engineering change control and document change control activities; participate in change control reviews.
  • Assume full ownership of PQ process validation planning, execution, and reporting; collaborate with R&D and Manufacturing/QC as required.
  • Assume full ownership of equipment and test fixture validation planning, execution, and reporting; collaborate with R&D and Manufacturing/QC as required.
  • Ensure effective training of Manufacturing and Quality Control (QC) personnel for transfer of new processes/methods.
  • Participate in design and implementation of new quality initiatives and programs.
  • Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols. Including scheduling, forecasting project requirements, and preparation of validation master plans.
  • Develop risk management plans, verification/validation plans, requirement traceability matrices, and summary reports in collaboration with cross-functional team members.
  • Resolve testing problems by modifying testing methods or revising test objectives and standards and prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
  • Ensure Process Capability Key Performance Indicators (KPIs) are tracked, communicated, and are used as tools to drive continuous improvement.
  • Participate in or conduct applicable departmental and interdepartmental training and provide training and oversight for stability study execution.
  • Advise and train other company personnel on specific Quality System topics and design changes to the manufacturing/ quality processes.
  • Responsible for knowledge transfer of new product designs being transferred into Operations.
  • Collaborate with manufacturing and quality departments to evaluate manufacturing areas to identify specific needs and potential issues.
  • Interact with manufacturing and quality teams to implement action items from NC investigations/dispositions, Corrective and preventative actions, design changes, and lean improvements.

Qualification: a minimum of a bachelor’s degree in biotechnology or a closely related field, is required from any candidate to perform the duties.

If interested, please send resumes to hr@pharmateksol.com

Job Features

Job CategoryValidation Engineer

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