• Senior Principal / Principal Engineer , Process Jobs in United States Of America - 25365857

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 1 - 4 Years
  • Posted : above 1 month

Job Description:

This position has the responsibility of providing manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new equipment, facilities, and/or utilities

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success We realize that our strength and competitive advantage lie with our people We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees

Duties & Responsibilities

Facilitate changes to existing production processes Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment Assist validation of new equipment and changes to existing equipment including document generation
Act as change control owner for equipment and process improvement projects Coordinate change control meetings Assign action items for change control Accountable for closing out change control action items and documentation Documentation includes P&ID drawings, functional specifications, detailed design specifications, Turn-over-packages, material specifications, and other documentation as required
Support manufacturing in troubleshooting product and equipment issues Drive the communication process between production and process engineering to identify issues with the manufacturing process and find long term solutions to these issues Identify improvements to manufacturing process Improvements may include mechanical, automation, or workflow Work with manufacturing and capital engineering on the development of future capital projects and on the development of requirements for the project Responsible for User Requirement Specification development
Lead small scale capital projects up to around $500,000 Lead process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects) Accountable for following capital process procedures and execution of project with regard to cost and schedule
On larger capital projects, the engineer will work with Capital Engineering and Equipment Vendors to ensure process requirements are communicated and built into the equipment/system design The engineer will develop specifications (user, functional, and detailed design) for equipment and automation of the equipment
Develop and maintain overall knowledge of facility processes and products Provide training on process and/or equipment modifications as required for new or existing equipment/processes Act as Subject Matter Expert for production equipment and processes for Capital Engineering, Production, Business Process Science, Quality Assurance, and Maintenance
Mentor less experienced process engineers in the performance of duties within the process engineering group


Principal Engineer, Process Requirements

Bachelor of Science Degree in Engineering or related science from accredited school
Five (5) years applicable experience, engineering or scientific in nature in a GMP environment OR 7 years engineering or scientific experience outside of a GMP environment
Communicate verbally and in writing effectively with all levels of corporate and local management and employees
Ability to plan, schedule, organize, prioritize, and coordinate project activities
Ability to understand and work within a regulated environment
Experience with GAMP Automation practices and documents preferred
Ability to function in a leadership role as well as in a team environment
Ability to manage multiple projects at one time
Comply with GMP and quality requirements when completing core duties

Senior Principal Engineer, Process Requirements

Bachelors degree in an engineering discipline or a related field (chemistry, physics, etc) plus 5 years of experience is strongly preferred Directly-applicable experience in a process engineering role (10 years) may also be considered, but is not preferred
Strong team orientation and ability to work cross functionally with various groups such as Safety, Quality, Maintenance, Purchasing, Industrial Development, R&D, and Manufacturing
Ability to read and interpret mechanical, electrical, and automation technical documentation (P&IDs, schematics, ladder logic, etc) and experience troubleshooting these systems
Experience using FMEA, RCA, or other risk based methodologies
Ability to execute multi-discipline assignments and ability to master new skills quickly
Ability to work independently with minimal supervision and direction
Ability to communicate information using tact and persuasion as appropriate requiring strong oral and written communication skills, organization, and leadership
Desire to spend time on the manufacturing floor in order to observe issues and identify solutions first hand
Experience using Excel, Word, PowerPoint, Outlook

Desired Skills, Experience and Abilities

Process engineering and/or process improvement experience
Experience with the following equipment is highly desired large scale upstream cell culture, fermentation and monolayer processing; downstream processing involving cross-flow filtration, centrifugation, chromatography, and sterile filtration; high-speed final product labeling and packaging The most significant and relevant experience desired involves aseptic formulation, high-speed vaccine filling, and freeze-drying
Ability to lead project teams and apply good project management techniques
Experience using Visio, Microsoft Project, AutoCAD, CMMS, and procurement software such as Oracle or SAP
Experience with FDA/cGMP regulations, equipment change control practices, and related quality systems
Experience with Lean and Six Sigma tools and methodologies

Eligibility Requirements

Must be legally authorized to work in the United States without restriction

Must be willing to take a drug test and post-offer physical (if required)

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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