Job Description

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you2019ll be supported in achieving your career goals.

Location/Division Specific Information

Drug Substance Division (DSD)/Biologics Business Unit/San Francisco, USA

How will you make an impact?

* Define and establish the core roles and responsibilities of a Plant Engineering function and how it interfaces with key stakeholders including Development, Manufacturing, Process Engineering, Facilities, QC Chemistry & Microbiology, Quality Assurance, and Program Management
* Ensure that all mission critical equipment/systems remain continuously ready for safe, effective, efficient, and compliant operations
* Establish and own the equipment and facility roadmap to support the site2019s capacity & capability plan
* Scope and lead capital investment projects

What will you do?

* Technical Leader with respective 201CMission Critical201D equipment/system/facility area
* Drive equipment capabilities and capacity to realize the site2019s growth trajectory
* Define user requirements for equipment, instrumentation, and other activities
* Create standard operating procedures in alignment with broader operational strategies
* Build business cases for new capital projects utilizing payback modeling
* Drive of Lean Manufacturing principles
* Scope development projects and basis of design
* System and field device troubleshooting and testing
* Establish and operate against an equipment/facility roadmap
* Establish & maintain the equipment compliance posture (Safety, Health, cGMP, BioSafety, Waste)
* Work with the Process Engineering department to support the facility fit analysis of new production processes
* Conduct all activities in accordance with cGMP, EH&S, and the site quality systems
* Behave as a Change Agent to drive innovation and operational effectiveness
* Engage with functional department leaders to establish an understanding of the needs/requirements of the department from an equipment capability and capacity perspective
* Contribute to equipment and space roadmap to support the site master plan
* Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning & qualification
* Responsible for the following 201CMission Critical201D Areas/Equipment/Systems for the Cell Therapy Facility:
* Cell Processing
* Plant & Clean Utilities
* Building Automation System (Cell Therapy Segment)
* Architectural, Facilities & Warehouse
* Laboratory & Analytical Instruments

How will you get here?

Education

* Bachelor2019s degree in Engineering discipline is required. Chemical or Biomedical Engineering preferred. Electrical, automation, mechanical, or other Engineering field acceptable with relevant work experience.

Experience

* Minimum of 2 years of equipment/facilities/systems engineering experience in Pharmaceuticals, preferably Biopharmaceuticals or Cell-based products

Knowledge, Skills, Abilities

* Strong understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles
* GMP and non-GMP change control, maintaining regulatory compliance
* Equipment reliability practices & methodologies
* Equipment specification, design, start-up, commissioning & qualification practice
* Defining, communicating and maintaining design and operability envelope
* Throughput analysis, facility fit, operational modeling
* Root cause investigations and troubleshooting
* Risk assessments
* Return on Investment, payback modeling
* Lean manufacturing principles
* Technical project management/scheduling/organization/budgeting
* Proficiency with AutoCAD

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.