Reliability Engineer

Azzur Solutions San Diego , CA 92122

Posted 2 weeks ago

Our client, a leader in the Pharma industry, is looking for Reliability Engineer to join their team.

  • Provide for the design and implementation of asset management programs including the development of governing SOPs and a process to categorize and prioritize equipment based on a life cycle methodology.
  • Integrate best demonstrated practice and industry standards into reliability and maintenance programs
  • Create detailed reliability standard operating procedures that encompass preventative and predictive methodologies and best practices
  • Create comprehensive maintenance management procedures which include elements such as:
    • Clear definition of the management process and maintenance strategies
    • CMMS management equipment classification and risk based analysis
    • Health and safety policies
    • Maintenance and repair operations (MRO) management
    • Project management of equipment modifications and improvements
    • Quality oversight and client specific requirements
    • GMP considerations
    • Maintenance assessments
    • Equipment documentation and change control
    • Equipment importance level assessments the corresponding failure based risk assessments.
  • Develop equipment specific preventative maintenance procedures based on risk based analysis and vendor recommendations
  • Develop new and/or update equipment operating procedures to cover maintenance frequency of new and existing assets.
  • Define pressure vessel safety requirements and relief device design and specification and maintenance
  • Develop Reliability Centered Maintenance (RCM) programs and the associated roadmaps and action plans to deploy programs across a facility.
  • Participate in FAT and commissioning of new or modified equipment.
  • Develop and implement cost/waste/energy reduction opportunities for equipment and facilitie

Requirements

  • BS in Engineering, Science or equivalent technical degree.
  • 2-5 years experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Ability to work effectively in a fast paced multitasking environment.
  • Strong working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • Working for multiple clients through out the region.

Benefits

  • Health Care Plan
  • Short Term & Long Term Disability
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Reliability Engineer

Azzur Solutions