Validation and Process Engineer

3 days ago

Blackpool, Blackpool, United Kingdom HCLTech Full time
Job Title: Validation and Process Engineer

We are seeking a highly motivated and detail-oriented individual to join our team as a Validation and Process Engineer. This role plays a critical part in ensuring that equipment and processes meet the highest standards of quality and compliance.

Key Responsibilities:
  • Preparation and Execution of Equipment Validation Protocols:
  • Develop and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment validation.
  • Ensure that all validation activities comply with industry standards and regulatory requirements.
  • Development & Execution of Test Method Validations:
  • Create and implement test method validation protocols to ensure reliable and reproducible testing methods.
  • Collaborate with quality, R&D, and manufacturing teams to ensure accurate execution and results analysis.
  • Process Characterization and Design of Experiments (DoE):
  • Perform process characterization and identify key process variables that influence performance.
  • Design, execute, and analyze experiments using Design of Experiments (DoE) methodologies to optimize processes and equipment performance.
  • Ensure all documentation is current and aligns with company standards and regulatory guidelines.
  • Prepare detailed validation reports and ensure that all findings, data, and results are properly documented.
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • 3+ years of experience in equipment validation, process characterization, or a similar role in the medical device, pharmaceutical, or manufacturing industry.
  • Experience with Test Method Validation (TMV) and statistical analysis.
  • Knowledge of PLM systems and Change Order (CO) processes.
Preferred Qualifications:
  • Experience in regulated industries such as medical devices or pharmaceuticals.
  • Knowledge of ISO 13485, FDA regulations, or other relevant regulatory standards.
  • Proficiency in software tools like Minitab, JMP, or similar for statistical analysis.
  • Ability to work independently and take ownership of complex projects.
  • High attention to detail and a commitment to producing quality work.

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