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CSV Engineer

  • Job reference: 924184
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 01/04/2019

Orion Group are recruiting a CSV Quality Engineer on an initial 12 month contract with one of our Multinational Medical Device Companies based in Northern Scotland.

Technical Competencies & Responsibilities

  • Lead CSV team, directing day-to-day tasks and planning for future deployment if required
  • Prioritise CSV team and own workload to meet deadlines and Implement day-to-day priorities in line with business needs if required
  • Serve as CSV department Subject Matter Expert (SME), represent Quality and present CSV validation documentation during internal and external inspections - recognised as the CSV go to person
  • Coach others in the CSV function, provide coaching, feedback and direction to project teams
  • Translates a given strategy into tactics and measures, independently. May participate in strategy development
  • Leads complex validation projects and projects within own function. Significant involvement in cross functional and global projects
  • Guide Project Managers, Project Owners & Project Teams regarding specific CSV requirements & responsibilities
  • Resolve & manage technical operational problems, provide solutions to difficult technical issues. Influence and persuade to bring about technical and process improvements
  • Resolves issues through constructive negotiation and professional behaviour.
  • Makes decisions based on data. Understands the balance of day-to-day activities versus big picture. Can assess risk and act appropriately
  • Keep management informed and escalates issues as appropriate
  • Ensure accuracy and maintenance of the LFSS computer systems list
  • Review and approve CSV validation and quality system documentation
  • Ensure validation activities and documents are authorised and appropriate compliance approval is gained
  • Provide periodic validation review support to current regulatory and company standards through the QMS
  • Proactive & forward thinking. Drives & implements continuous CSV function and process improvement activities. Implementing initiatives that will deliver customer value at lowest cost
  • Develop and build relationships externally and internally for the CSV function.
  • Influence business partners & suppliers to ensure product quality and compliance to quality systems
  • Leads CSV activities related to transfer of product design into operations
  • Understands the breadth of quality system and how it fits into the wider business perspective

Global Leadership Principles

Required:

  • Results & performance driven
  • Sense of urgency
  • Strategic thinking
  • Big picture orientation
  • Prudent risk taking
  • Collaboration & teaming
  • Self-awareness & adaptability

Qualifications

Required:

Degree qualification in an appropriate engineering discipline or equivalent work or job-related experience within in a regulated industry

Formal problem solving techniques, e.g. PeX green belt certification

Knowledge

Required:

SME knowledge of computer systems & software design, development and validation

Quality systems

Working knowledge of design control

Product lifecycle and manufacturing knowledge

Risk management tools e.g. FMEA, SRA, DOE

Software configuration management and change control

Working knowledge of FDA & European Regulations relating to the Medical Devices Industry and best practices guidelines i.e. 21 CFR Part 11, 820 & ISO 13485 and GAMP

Knowledge of bespoke computer systems, software/application and hardware specification, development, testing and documentation within a regulated industry

Knowledge of automated manufacturing equipment, inspections systems, PLC, SCADA & DCS, specification, development, testing and validation

Skill

Required:

Self-motivated/directed; ability to work with minimal direct supervision

Project management

Meeting management

Technical leadership

Proactive approach to problem identification and proactive problem resolution

Facilitation and constructive negotiation

Quality acumen

Resilient and ability to work under pressure

Technical training / coaching of staff

Software configuration management and change control

Trouble shooting and problem solving skills

Desirable:

Financial awareness

Leadership & influence, give direction

Lean experience

Mentoring of staff

Process excellence methods and processes


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.