Validation Engineer (CQV)

GMP Healthcare Ltd is a consultancy service provider for the pharmaceutical, medical device, and food supplements industry. Our team of over 100 professionals offers support across all GxPs and provides expertise throughout the product life-cycle and manufacturing process. With a diverse range of specialists in various fields, we offer over 400 years of industry know-how to our clients.

Role and Responsibilities

As Validation Engineer you will be responsible for the below roles and responsibilities.: -

• Responsible for executing validation and qualification activities, authoring and reporting validation activities within the framework of cGMP – Annex 11 & 15 and in compliance with QMS requirements.
• Management of compliance to Business and Engineering Quality standards
• Ensuring Engineering design meets safety standards for emissions
• Validating support to project management team
• Review equipment maintenance history, investigation and audit support, process/component improvement project support, and reliability engineering support.
• The primary skill of the role requires the applicant to have a good working knowledge of Validation requirements for Equipment / Facilities / Utilities including associated control systems. In addition, a working knowledge in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and associated computerised system validation within the pharmaceutical environment, it is anticipated that this role will become the CSV stream SME.
• Ability to write User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation and / or trial purposes
• Ability to translate local, corporate and regulatory requirements into validation requirements
• Day to day management and coordination of Validation Engineering project activities between key stake holders
• Have a detailed understanding of GMP, quality assurance and documentation systems in a pharmaceutical environment.
• Possess a broad knowledge of validation practices, standards and regulatory requirements/expectations i.e. Annex 11 & 15 and industrial guidelines such as GAMP.
• Provide validation engineering technical support related to the operation, maintenance, installation, start-up/commissioning, testing, and qualification of Lifesciences process equipment and related systems within a manufacturing facility.
• Experience developing a Master Validation Plans and writing Validation Summary Reports.
• Must understand Change Control and Change Reporting (as it pertains to validation)
• Provide input to process equipment design, development of start-up documents, commissioning plans, and execution of commissioning plans.

Knowledge, Training & Experience

• Bachelor’s degree in mechanical, electrical, or chemical engineering or related field, or equivalent experience.
• Comprehensive and understanding of complex manufacturing processes.
• Working knowledge of Good Manufacturing Practice type systems and practices in a manufacturing environment.
• Ability to communicate and express ideas clearly, across all levels of the organization
• Skilled in Microsoft Office applications including Project, Word, Excel

GMP Manufacturing Ltd