Roche

Principal Instrumentation & Controls Plant Engineer – CVRM

Roche

full-time

Posted on:

Location Type: Hybrid

Location: Holly Springs • California • North Carolina • United States

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Salary

💰 $95,200 - $176,800 per year

Job Level

Lead

About the role

  • You will drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements.
  • This includes inputs to the creation of calibration master data in SAP S4/HANA our Computerized Calibration Management Software.
  • You will champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management.
  • This also includes provision and realization of creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects.
  • Presents ideas, project goals, progress, risks, and results across departments and to senior management.
  • You will serve as backline technical support and troubleshooting for the site’s instrumentation.
  • This includes in the field troubleshooting, root cause analysis, and deviation, change control, and CAPA ownership.
  • This will require strong collaboration with Automation, Validation, Calibration, Quality, and Manufacturing.
  • You will develop and optimize a reliability program for Instrumentation and proactively manage instrumentation obsolescence.
  • You understand the bigger picture of the project and the CVRM disease area and how PT contributes to it.
  • Works closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals.
  • Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views.
  • You will provide leadership for involved project teams and across the broader organisation.
  • Provides training materials and training for people joining the organisation.
  • Acts as a coach for colleagues with less experience and helps them develop skills/expertise.

Requirements

  • You have a bachelor's degree and 5+ years of work experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment with Instrumentation.
  • You have an ability to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
  • You have updated knowledge of cGMP’s, Health Authority regulations, and Quality Systems.
  • You have experience with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters.
  • Utilizes an established network for technical issues within the company and the industry.
  • You have strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources.
  • Coaches others.
Benefits
  • A discretionary annual bonus may be available based on individual and Company performance
  • Relocation benefits are provided
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
calibration master dataroot cause analysisdeviation controlchange controlCAPA ownershipreliability program developmentinstrumentation troubleshootingmanufacturing efficiencyproject managementdigital transformation
Soft Skills
collaborationleadershipcoachingproblem-solvinginfluencingcommunicationorganizational skillscreativityinnovationstakeholder management