Validation Engineer

Orion Electrotech Ltd
16 May 2018
24 May 2018
Contract Type
Full Time
We are a growing international specialist healthcare company. Our mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients. Due to continued growth, we have an exciting opportunity for a Validation Engineer to join our team in Farnham.

The Validation Engineer will lead and execute the complete delivery of validation projects and activities for manufacturing at the Farnham site, ensuring all goods manufactured and services provided by the company meet the quality requirements of the business, customers and regulatory authorities.

Principal Responsibilities

*To lead and execute validation activities and validation assignments supporting all technical, manufacturing and packaging activities at the Farnham site involving the qualification of new and existing facilities, utilities, equipment and computerised systems.

*Generation of related project documentation including, but not limited to; validation plans, protocols, reports

*Execution of validation testing for manufacturing and packaging equipment, utility systems equipment and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.

*Continuously improve methods of validation in line with Regulatory requirements that ensure the company is at the forefront of current thinking and are applying best available technique.

*Support the Technical Compliance, Commercial Development, Engineering and Manufacturing teams with items related to Validation.

Education and Experience

*Degree in an appropriate scientific discipline and/or relative industrial experience

*Experience in pharmaceutical and/or medical device process and equipment commissioning/qualification for manufacturing/packaging equipment, computer systems, facilities and utilities

*Experience in front line involvement with Regulatory Inspections.

*Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements.

*Strong technical background, gained from a highly regulated environment: pharmaceutical, biotechnology or related industry, including exposure to the regulatory requirements affecting validation

*Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices.

Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.

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