Principal Process Engineer, Lyophilization - Boehringer Ingelheim
Athens, GA
About the Job
Description
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 several 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 Ingelheim's high regard for our employees.
The Principal Engineer, Lyophilization will be responsible for providing technical expertise in support of lyophilization equipment/process and refrigerated storage. This position develops and oversees Lyophilization process recipes and equipment optimal operation. The incumbent works with Production and department supervision to ensure Lyophilizers and refrigerated storage systems are maintained and operated in the highest state of reliability possible, including equipment alteration for improvement. This role troubleshoots lyophilization process issues to determine root cause and identify the proper solution. This position will also provide technical instructions, training and development to Maintenance Technicians during operation and maintenance of these systems.
Duties & Responsibilities
+ Develops Lyophilization process recipes, ensuring proper operation and reliability. Selects proper equipment for the operation of refrigerated storage.
+ Ensures maintenance and reliability of the lyophilization and refrigeration equipment.
+ Responsible for the proper equipment operation and troubleshooting of Lyophilizers and refrigerated storage systems and effecting necessary repairs. Selects proper parts for alteration of equipment.
+ Responsible for the preventive maintenance instructions for these equipment.
+ Effectively utilizes statistical methods to monitor and understand process variation routinely and recommend appropriate action based on trends.
+ Maintains departmental performance metrics ensuring clear visibility at the floor level, management level, and site level.
+ Works with deviations occurring in the lyophilization and refrigeration areas, including root cause analysis, CAPA development, and CAPA implementation.
+ Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Engineering and Purchasing to aid in effectively meeting site objectives.
+ Demonstrates a visible and tangible commitment to EHS and the BI Values in all work-related activities.
Requirements
+ BS in Engineering; BS in Biology or related field.
+ Minimum of seven (7) years on the job experience in the refrigeration field.
+ Formal Lyophilization training is desired.
+ Demonstrated knowledge and understanding of biopharmaceutical regulations and good manufacturing practices and demonstrated ability to understand and work within a regulated environment.
+ Excellent communication skills, both verbally and written.
+ Ability to lead/manage effective meetings both within and outside of the department.
+ Ability to communicate with a diverse population, including vendors, consultants, BIVI functions, etc.
+ Fluency in Microsoft Office software.
+ Statistical analysis experience.
+ Demonstrated ability to apply analytical stills to identify problems, recognize symptoms, causes and provide alternative solutions.
+ Effective project management skills planning, scheduling, organizing, prioritizing, and coordinating project activities.
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).
+ Must be 18 years of age or older.
Desired Skills, Experience and Abilities
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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 several 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 Ingelheim's high regard for our employees.
The Principal Engineer, Lyophilization will be responsible for providing technical expertise in support of lyophilization equipment/process and refrigerated storage. This position develops and oversees Lyophilization process recipes and equipment optimal operation. The incumbent works with Production and department supervision to ensure Lyophilizers and refrigerated storage systems are maintained and operated in the highest state of reliability possible, including equipment alteration for improvement. This role troubleshoots lyophilization process issues to determine root cause and identify the proper solution. This position will also provide technical instructions, training and development to Maintenance Technicians during operation and maintenance of these systems.
Duties & Responsibilities
+ Develops Lyophilization process recipes, ensuring proper operation and reliability. Selects proper equipment for the operation of refrigerated storage.
+ Ensures maintenance and reliability of the lyophilization and refrigeration equipment.
+ Responsible for the proper equipment operation and troubleshooting of Lyophilizers and refrigerated storage systems and effecting necessary repairs. Selects proper parts for alteration of equipment.
+ Responsible for the preventive maintenance instructions for these equipment.
+ Effectively utilizes statistical methods to monitor and understand process variation routinely and recommend appropriate action based on trends.
+ Maintains departmental performance metrics ensuring clear visibility at the floor level, management level, and site level.
+ Works with deviations occurring in the lyophilization and refrigeration areas, including root cause analysis, CAPA development, and CAPA implementation.
+ Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Engineering and Purchasing to aid in effectively meeting site objectives.
+ Demonstrates a visible and tangible commitment to EHS and the BI Values in all work-related activities.
Requirements
+ BS in Engineering; BS in Biology or related field.
+ Minimum of seven (7) years on the job experience in the refrigeration field.
+ Formal Lyophilization training is desired.
+ Demonstrated knowledge and understanding of biopharmaceutical regulations and good manufacturing practices and demonstrated ability to understand and work within a regulated environment.
+ Excellent communication skills, both verbally and written.
+ Ability to lead/manage effective meetings both within and outside of the department.
+ Ability to communicate with a diverse population, including vendors, consultants, BIVI functions, etc.
+ Fluency in Microsoft Office software.
+ Statistical analysis experience.
+ Demonstrated ability to apply analytical stills to identify problems, recognize symptoms, causes and provide alternative solutions.
+ Effective project management skills planning, scheduling, organizing, prioritizing, and coordinating project activities.
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).
+ Must be 18 years of age or older.
Desired Skills, Experience and Abilities
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim