Validation Engineer

Dart Recruitment
08 Mar 2018
14 Mar 2018
Contract Type
Full Time
Validation Engineer - £35-55k
This is an opportunity to join a growing International Pharmaceutical Company, the role will be to lead and execute the complete delivery of all 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 Company, customers and regulatory authorities.
Principal Responsibilities
  1. To lead and execute Validation activities and Validation assignments supporting all manufacturing and packaging activities at the Farnham site involving the qualification of new and existing facilities, utilities, equipment (including sterilization) and computerized systems.
  2. Generation of related project documentation including but not limited to validation plans, protocols, reports
  3. 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.
  4. Continuously improve methods of validation in line with Regulatory requirements that ensure the Client is at the forefront of current thinking and are applying best available technique.
  5. Support the Technical Compliance, Commercial Development, Engineering and Manufacturing teams with items related to Validation.
  6. Represent the Group at all Regulatory Inspections.
  7. Ensure that all critical changes are impact assessed and that appropriate controls/actions are in place to secure ongoing manufacture.
  8. Training of staff in Validation procedures and principles
  9. Support other departmental activities as requested by department management or designate.
  10. Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with values.
  11. Carry out other reasonable tasks as required by the Line Manager.

Education and Experience
  1. Degree in an appropriate scientific discipline, and/or relative industrial experience.
  2. Experience in pharmaceutical and/or medical device process and equipment commissioning/qualification for manufacturing/packaging equipment, computer systems, facilities and utilities
  3. Experience in front line involvement with Regulatory Inspections.
  4. Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements.
  5. Strong technical background, gained from a highly regulated environment: pharmaceutical, biotechnology or related industry, including exposure to the regulatory requirements affecting validation
  6. Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices.

Skills and Attributes
  1. Technical knowledge, high standards of attention to detail and the desire to see tasks through to completion.
  2. Must be "hands-On" with a wide breadth of validation knowledge to allow adaptability to the different types of validation.
  3. Ability to identify, organize and communicate complex technical problems with strong attention to detail and organizational skills.
  4. Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups due to the changeable, team-oriented, project nature of the work.
  5. Proven ability and desire to continuously improve, by seeking new approaches, generating ideas and demonstrating a determination to secure business advantage from such initiatives.
  6. Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail.

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