Boehringer Ingelheim Pharmaceuticals, Inc

SR Engineer, Process

Boehringer Ingelheim Pharmaceuticals, Inc • $75K — $95K *
Athens, OH 45701In-Person
Manufacturing & Automotive
Less than 5 years of experience
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Job Overview by Ladders

Qualifications

  • Bachelor of Science in Engineering (or related) with 1-3 years of experience in a GMP environment, or 3-5 years in a non-GMP setting.
  • Master's Degree in a relevant field with at least 1 year of GMP experience or 2 years of scientific experience outside of GMP.
  • Minimum of 1 year experience leading projects.
  • Familiarity with GAMP Automation practices is preferred.
  • Knowledge of GMP regulatory requirements.

Responsibilities

  • Facilitate changes to existing production processes.
  • Lead installation and start-up of new equipment and modifications to existing equipment.
  • Assist in validating new equipment and create necessary documentation.
  • Coordinate change control meetings and own related documentation.
  • Support troubleshooting in biomanufacturing and packaging areas.

Benefits

  • Comprehensive healthcare coverage.
  • Retirement savings plan with company match.
  • Professional development opportunities.
  • Generous paid time off policy.
Full Job Description
The SR Engineer, Process 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.

Duties & Responsibilities

  • Facilitates changes to existing production processes.
  • Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment.
  • Assists with validation of new equipment and changes to existing equipment including document generation.
  • Acts as change control owner for equipment and process improvement projects. Coordinate change control meetings.
  • Assigns action items for change control.
  • Accountable for change control action items and documentation. Documentation includes drawings, functional specifications, detailed design specifications, Turn-over-packages, material specifications, and other documentation as required.
  • Supports troubleshooting product and equipment issues in production areas such as biomanufacturing, formulation and filling, lyophilization and packaging.
  • 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.
  • Assists cross functional teams in the execution of small-scale capital projects up to around $500,000, process improvement projects, continuous improvement projects, and equipment improvement projects.
  • On larger capital projects, the engineer will be responsible for to ensuring 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.
  • 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.


Requirements

  • Bachelor of Science Degree in Engineering from an accredited school with one to three (1-3) years applicable experience in a GMP environment or Bachelor's degree with three to five (3-5) of engineering or scientific experience outside of a GMP environment.
  • In lieu of years of experience, Master's Degree in relevant field from an accredited school with one (1) year experience in a GMP environment or at least one (1) year of engineering or two (2) years of scientific experience outside of a GMP environment.
  • At least one (1) year of experience leading projects preferable.

Competencies:
  • Effective verbal and written communication 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.

Skills:
  • Analytical Thinking
  • Data collection and analysis
  • Communication
  • Customer Focus
  • Data-driven Decision Making
  • Planning and Organizing
  • Teamwork
  • Conceptual / Analytical Thinking Scope
  • Delivering Results
  • Leadership


Desired Skills, Experience and Abilities

About Boehringer Ingelheim Pharmaceuticals, Inc

Boehringer Ingelheim Pharmaceuticals, Inc. is a research-driven pharmaceutical company that discovers, develops, and manufactures prescription medicines. The company's mission is to improve the health and quality of life of patients by developing innovative therapies. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of Boehringer Ingelheim Corporation, which is headquartered in Ingelheim, Germany. The company's research and development efforts focus on respiratory diseases, immunology, oncology, and diseases of the central nervous system. Boehringer Ingelheim Pharmaceuticals, Inc. was founded in 1885 and is based in Ridgefield, Connecticut.
Learn more about Boehringer Ingelheim Pharmaceuticals, Inc
Size
5,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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