Process System Engineer

Job description

·  Job facts

Leadership & People Management:

· 
Creates and promotes an environment of strong team approach, timely and effective communications, sense of urgency, high motivation and inspires teams to achieve goals in the short and long term.

· 
Leads and participates in cross-functional and cross-site activities aimed at defining best practices and improving systems' performance.

· 
Provides mentoring and coaching of engineers, operation and process mechanics and maintenance technicians, and where necessary develops and conducts process/engineering related training.

· 
Provides Engineering/technical input to MSAT, Quality, Operation, Engineering, Validation, and Automation groups with regard to discrepancies, investigations, document reversions, equipment and automation changes.

· 
Provide technical and SME leadership, knowledge and training to multi-disciplinary manufacturing teams on complex process and equipment technologies, system troubleshooting, development of procedures, and system components' analysis.

· 
Actively participate in manufacturing network-related, cross-functional investigations and industry summits.

· 
Promote culture of safety and quality that supports continuous improvement in collaboration with the Environmental, Health & Safety (SHE) management and Quality / Validation (QEV) management systems through active communication and functional area participation in site safety and quality teams.

· 
Coordinates and interacts with System Owners teams; Engineering; Quality / Validation; QA; Manufacturing Science and Technology group; Facility, Maintenance and Metrology; Environmental, Health & Safety (SHE); Manufacturing teams; Manufacturing Planners / Schedulers; Material Management group.

· 
When required, participates and provides guidance in Stage Gate project reviews, Site Management and Stakeholders meetings, Product Councils as related to the System Class

· 
Participates and provides technical guidance to the review teams in SHE lead and QV lead Risk Analysis, Deviation and Asset malfunction investigations, process studies

· 
Presents and participates in the industry-wide collaborative efforts (e.g. ISPE, PDA, AIChE) as relates to all aspects of the System Class design, installation, commissioning, operation, maintenance / inspection

Technical:

· 
Working knowledge of FDA cGMP regulations, applicable bio-pharmaceutical industry Good Engineering Practices, and familiarity with governing codes and guidelines.

· 
Strong ability to size, rate, select, and scale the process system components that include equipment, instrumentation, valves, and piping

· 
Collaborates with System Owners' teams in leading and managing the evaluation and investigation of CAPA, DMS and recurring failures, initiate and follow through the implementation of the robust changes to prevent failures through SOP, WI, equipment/ automation/ process changes and cross functional training.

· 
Leads and participates in equipment failure related investigation / Root Cause Analysis (RCA).

· 
Develops a multi-purpose simulation and mechanical/physical proof of concept for process improvements, failure analysis, hypothesis testing, prototype testing and training.

· 
Responsible for reviewing and revising URS and Functional Specifications, Systems Impact / Criticality Analysis

· 
Develop and advance project initiation phase and conceptual design phase (PI and CD) technical design packages and deliverables (e.g. PFDs/P&IDs, Equipment Data Sheets, Cycle / Operational Time Analysis and Material / Waste Balances, Equipment and Component sizing) for complex equipment /automation design development and changes. Conduct Engineering design review (EDR) and approval of proposed process equipment modifications related changes associated with automation, mechanical and/or process from other disciplines.

· 
When required, provide a Project Management oversight, and develop early phase Project Execution Plan (PEP), Project Charter, Project Organization Chart, project schedules, estimates, resource loading, as well as project metrics and reporting.

· 
When required, provide technical input and assist in preparation of Commissioning and Qualification (IQ/OQ/PQ) Protocols, FAT/SAT testing requirements,

· 
Reviews and approves of completion of turnover packages (TOPs), project related vendor documents and drawings.

· 
Provides review and approval of Change Requests (CRs) that are related to engineering changes.

· 
Provides SME oversight to obsolete spare part replacement. Assess fit for use, parts availability or possible replacement of system components.

· 
Assist System Owner teams to coordinate and interpret operational data extracted from Batch Historian, through field observations, or compilation of study data. Provide evaluation of design changes based on equipment performance and develop improvements.

Job Requirements

Education

· 
Bachelor Degree in Chemical or Bio-Chemical Engineering is preferred. Degrees in Mechanical, Structural, and Nuclear Engineering are considered.

Experience

· 
12-15 years of engineering design, troubleshooting, and/or operational experience

Knowledge/Skills/Competencies

· 
Demonstrates a complete quantitative and qualitative understanding of process engineering principles and concepts with an ability to provide solutions to complex technical problems in the bio-pharmaceutical processing.

· 
Ability to manage projects and coordinate development of early phases' project deliverables.

· 
Complete technical, design, and operational competence of specific System Classes and their integral components, and good understanding of complete Mammalian Cell Culture Process Upstream, Downstream, Process Supports and Utilities functions.

· 
Experience with Cell Culture process system components' troubleshooting, event Root Cause Analysis, and System Reliability and Integrity

· 
Capable of providing creative, out of the box approaches to design and operating challenges

· 
Proven ability to understand Project Management concepts and execution phases / deliverables for each phase

· 
Working knowledge of applicable Quality Systems (e.g. Clean Utilities, sampling /QC)

· 
Working knowledge of cGMP practices, experience of working in a cGMP environment

· 
Excellent written, verbal, and presentation skills with proven ability to use market available software

Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.