CSV Engineers, Control Systems

CSV Carlsbad, California


Description

Basic Qualifications & Position Requirements:

Required Education:

  • Bachelors Degree in engineering, science, or equivalent technical degree

Preferred Education:

  • Masters Degree in engineering, science, or equivalent technical degree

Required Work Experience: 

  • 10+ years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Experience in developing lifecycle documentation for computer systems (e.g. requirements specifications, risk assessments, plans, traceability matrix, protocols, reports)

·         Validation of manufacturing control systems

·         Validation of building automation/management systems

  • Experience with project management

Preferred experience:

·         Experience with validation of Emerson DeltaV DCS Systems

·         Experience with validation of Werum MES systems

 

Required Knowledge:

  • Strong knowledge of FDA and cGMP regulations and documentation practices
  • Strong knowledge of GAMP 5
  • Strong knowledge of 21 CFR Part 11 and Annex 11
  • Strong knowledge of computer system validation methodologies
  • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Proficient in Microsoft Word, Excel, and PowerPoint

Preferred Knowledge:

  • Network infrastructure
  • ISA-195 and ISA-88 standards.
  • IEC 62304, ISO13485 regulated Quality system
  • Medical device software V&V (embedded software)

Skills

  • Mathematical Skills
  • Computer Skills
  • Project Management
  • Creating and fostering a team based environment
  • Ability to oversee the work of subordinates and contractors while maintaining critical project schedules
  • Coaching and mentoring skills

Additional Qualifications:

  • Customer service/client relations
  • Communication proficiency
  • Attention to detail
  • Can work productively independently with minor supervision
  • Self-motivated, flexible, dependable and available
Excellent organizational and time management skills

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.