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Validation Manager

  • Job reference: 927235
  • Location: England
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 22/08/2019

Orion Group are looking for a Validation Manager for our Multinational Medical Devices client based in the North Scotland area on a permanent basis.

Job Purpose
Reporting to the Director, Quality Operations, you will be responsible for managing a group of validation experts in the Quality Operations Department. You will also define the Validation requirements across the business - Equipment, Process, Test method, Software Validation and continuous process verification and, also ensure the following systems, Equipment, Facility, Utility, Plant, Room, Process, Software, Spreadsheet, Hardware, Material and IT are in compliance with applicable regulations.

This role also includes but is not limited to the execution of the Quality processes, Health and Safety of staff, people development, validation execution and managing budget and you will be a key member of the Quality Leadership Team.

Main Responsibilities of the role

  • To lead and shape the team
  • Management of staff including direction, performance management and feedback, motivation, salary review, training and feedback
  • Validation department Subject Matter Expert (SME), represent Quality and present validation process documentation during Regulatory Inspections
  • Is recognised as Validation go to person
  • Mentor and coach others in the Validation function and across franchise. Provide coaching, feedback and direction to direct reports and project teams
  • Translates a given strategy into tactics and measures, independently. Leads strategy development for Validation function
  • Leads complex validation projects and projects within own function. Leads cross functional and global projects
  • Goal Setting, prioritization, planning, resourcing and review of Quality performance metrics
  • Works with key business partners (including manufacturing managers and IT Management) to define strategy and tactics for improving Validation Processes
  • Planning of resources within own area to meet the strategic plan and the day-to-day needs of the Business
  • Compliance to all Health & Safety, Quality and Regulatory requirements including GMP (QSR, QSIT), ISO 9001, EN46000
  • Define appropriate training programmes to enhance competency to future business needs
  • Develop and implement quality systems improvements
  • Develop financial acumen within own area of responsibility

Desired Experience and Background of the successful candidate

  • A minimum of a Bachelor's degree required in a relevant discipline such as Electrical/ Electronic Engineering, Information Systems or Life Sciences
  • Ideally have Chartered Member with advanced problem solving techniques such as black belt certified
  • Strong team management experience of verification and validation methods with medical devices or pharmaceuticals
  • Knowledge of bespoke software and/or hardware build, testing, documentation and deployment as part of software and/or system development lifecycle
  • In-depth knowledge of Medical Device or Pharma industry regulations; FDA, ISO, and industry best practices; GAMP/PICS
  • Knowledge of document and change management process
  • Working knowledge of risk management tools e.g. FMEA, FTA or SRA
  • Proactive problem resolution
  • Financial acumen
  • Strong understanding of Validation types, Process, Equipment, Software, Test Method and Cleaning Validation
  • Strong understanding of IQ, OQ, PQ processes
  • You will have diversity of thought teamed with a strong customer focus and it goes without saying that you will have a proactive approach to issue identification and problem resolution as well as being resilient and able to work well under pressure

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.