Hybrid Principal Instrumentation & Controls Plant Engineer – CVRM

at Roche

• Job title: Principal Instrumentation & Controls Plant Engineer – CVRM
• Job type: Full Time
• Experience level: Lead
• Salary: $95,200 - $176,800 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Holly Springs, United States

About the role

• Principal Engineer overseeing instrumentation and controls for new Drug Product manufacturing facility at Roche. Collaborating across teams to ensure operational efficiency and compliance.

Responsibilities

• 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