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Boehringer Ingelheim · 2 days ago
Principal/Sr. Principal Engineer, Process
Athens, GA
Full-time
Onsite
Senior Level
4+ years exp
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Responsibilities
Facilitates changes to existing production processes
Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment
Assists validation of new equipment and changes to existing equipment including document generation
Acts as change control owner for equipment and process improvement projects
Coordinates change control meetings. Assigns 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
Supports manufacturing in troubleshooting product and equipment issues
Drives the communication process between production and process engineering to identify issues with the manufacturing process and find long term solutions to these issues
Identifies improvements to manufacturing process. Improvements may include mechanical, automation, or workflow
Works 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. Leads small scale capital projects up to around $500,000
Leads process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects)
Accountable for following capital process procedures and execution of project regarding cost and schedule
On larger capital projects, works with Capital Engineering and Equipment Vendors to ensure process requirements are communicated and built into the equipment/system design
Develops specifications (user, functional, and detailed design) for equipment and automation of the equipment
Develops and maintains overall knowledge of facility processes and products
Provides training on process and/or equipment modifications as required for new or existing equipment/processes
Acts as Subject Matter Expert for production equipment and processes for Capital Engineering, Production, Business Process Science, Quality Assurance, and Maintenance
May be responsible for leading, directing, coaching, and developing up to seven junior engineers within the site's process engineering organization
Analyze new and existing processes. Eliminate sources of contamination, waste, and risk. Optimize efficiency and yield. Identify and drive corrective actions. Lead without authority. Manage projects related to risk reduction and/or process improvement.
Qualification
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Required
Bachelor's degree in Engineering or related field with ten (10) years of experience in a relevant scientific discipline, OR Master's degree, eight (8) years of experience in a relevant scientific discipline
Ability to 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
Ability to function in a leadership role as well as in a team environment
Ability to manage multiple projects at one time
Ability to directly manage one or more internal or external resources
Bachelor of Science Degree in Engineering or related science from accredited school
In addition to degree, a minimum of four (4) years applicable experience, engineering or scientific in nature in a cGMP environment or similarly regulated environment, OR Minimum of seven (7) years engineering or scientific experience outside of a cGMP/non-regulated environment
Experience must be inclusive of at least (3) three years leading moderate to complex CAPEX, process improvement, and/or related engineering projects.
Preferred
Eight-plus (8+) years applicable experience engineering or scientific in nature in a GMP environment
Experience with GAMP Automation practices and documents
Basic working knowledge of Allen-Bradley and/or Siemens PLCs (Programmable Logic Controllers)
Lean Six Sigma Green Belt (or higher) certification
Certified Maintenance & Reliability Professional (CMRP) certification
Five-plus (5+) years’ experience leading projects
Experience using, developing, and leading recognized process optimization tools in a manufacturing facility
Extensive direct experience in a leading role with the design, implementation, formal qualification, optimization and troubleshooting of aseptic manufacturing processes and equipment.
Experience with GAMP Automation practices and documents preferred.
Benefits
Competitive compensation and benefit programs
Healthy working environment
Meaningful work
Diversity and inclusion
Mobility
Networking
Work-life balance
Company
Boehringer Ingelheim
Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.
Founded in 1885Ingelheim Am Rhein, Rheinland-Pfalz, DEU
10,001+ employees
Funding
Current Stage
Late StageLeadership Team
Christian Eckermann
SVP, Head of Biopharma Austria
Clive Wood
Senior Vice President
Recent News
Business Wire
2024-06-03
Global Legal Chronicle
2024-05-31
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2024-05-28
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