Validation Engineer

North West England
£30 - £38 per annum
20 Feb 2013
20 Mar 2013
Adam Metcalf
Contract Type
Full Time

Validation Engineer is required for an initial 6 Month contract with a company residing in theNorth West

Job Purpose:

* Provision of Engineering input into site validation program. This will include, amongst other activities, compilation and improvement of work instructions and operating procedures for manufacturing processes, pFMEA activity to identify areas of significant risk and completion of protocols and processes that ensure the site meets the corporate validation requirements.
* Champion and drive designing quality in to the processes on site
* To provide support to ensure EHS, Business Continuity and Group Insurance requirements and standards are met.
* To keep up to date with industry standards and best practice and be able to replicate that best practice into Rossendale facility.
* Through identification of risks through pFMEA process and through other validation activities, deliver process and facility improvements that will result in better operational effectiveness, efficiency, economics and product quality


* This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes).
* Through implementation of validation processes, assure regulatory and company policy compliance of all engineering activities with regards to manufacturing processes and product quality.
* Take responsibility for the quality of the products and processes on site to ensure compliance to the sites quality management system and also to ensure that any improvement opportunities are identified.
* Lead, coach and support employees from engineering and other departments in validation activities
* Observe all safety and security procedures
* Trouble shoot problems; suggest and implement corrective actions
* Participate in company facilitated training and development programs designed to increase knowledge in issues related to medical device manufacturing and development such as GMP, TPM, Lean Manufacturing and Total Quality

Technical Knowledge and Skills:

* Degree in related subject, with considerable professional level Quality / manufacturing engineering experience in a regulated industry, or a combination of education and experience that provides comparable learning
* Knowledge and skill in engineering documentation procedures, development methods and project management
* Medical device industry or pharmaceutical industry experience required.
* Good level of GCSE English and Mathematics qualification or equivalent standard in a relevant discipline is required
* Strong computer knowledge is required to include Windows, Word, Excel, PowerPoint and MS Office Suite


* Ability to coordinate and lead project team activities in an effective and proficient manner. Team members typically include diverse inter-department staff including Regulatory, Marketing, Purchasing, Operations and R&D. Leading these cross functional teams requires a significant level of organization and motivation skills.
* Ability to handle and work under stressful situations
* Ability to establish effective working relationships with co-workers and subordinates; able to provide direction and feedback to employees
* Ability to recognize training needs and to coach employees as needed
* Excellent verbal and written communication needed along with the ability to prioritize and manage multiple tasks concurrently
* Ability to train associates in all aspects of process and equipment validation
* Ability to effectively and quickly address problems as they arise

Planning and Decision Making:

* Ability to plan and coordinate resources to meet deadlines
* Demonstrated use of considerable judgment in the planning, scheduling and coordinating of project phases as well as the selection of engineering techniques and criteria
* Ability to plan, schedule and coordinate projects and to lead the project team activities effectively with the required end result in mind.
* Ability to plan and conduct effective meetings and group presentations
* Works under only general supervision, with direction given only in terms of broadly stated objectives and desired outcomes
* Ability to coordinate and lead internal & external project team activities in an efficient and effective manner

To find out more about Huxley Associates, please visit

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