Principal Engineer, Downstream/ Drug Product - Boehringer Ingelheim
Fremont, CA
About the Job
Description
The primary purpose of the position is to lead and manage several projects within the Downstream (DS) and Drug Product (DP) Manufacturing Science and Technology (MSAT) group. The Principal Engineer frequently solves complex problems with some precedent and occasionally unprecedented complex scientific and manufacturing problems based on experience and scientific and engineering knowledge. Leadership includes leading teams, coaching and mentoring junior staff, driving initiates to increase efficiency and the robustness of operations and promoting effective cross functional communications and collaborations. The Principal Engineer must provide technical and scientific expertise to specific areas of responsibility of the DS and DP MSAT group. The position holder must be an effective representative of BIFI and BI in interactions with regulators and high level customers as Subject Matter Expert (SME). The Principal Engineer must live the BI values and promote a positive work environment for others. The position supports and occasionally leads Initial Facility Fits into the DS and DP GMP manufacturing areas. The Principal Engineer ensures that conclusions reached and recommendations made are scientifically defensible and adhere to all Quality standards, executes against deliverables developed by the department leadership, and creates proposals to improve operational efficiency. The Principal Engineer regularly serves as Process Science representative on project teams. This position may lead New Product Introduction and GMP operation in the Disposables Clinical Manufacturing Facility to produce drug substance under GMP/GLP conditions for toxicology and clinical studies. 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 Ingelheim's high regard for our employees
Duties & Responsibilities
+ This position plans and executes complex scale-up and characterization activities of Downstream and Drug Product manufacturing processes in a robust and scientific manner leading to predictable process performance and a well characterized process. The Principal Engineer utilizes scale-up experience, facility specific knowledge, and engineering principals to introduce new processes into Manufacturing and consistently deliver the expected process performance across all new products.
+ The position develops and executes plans independently to determine root cause of process related deviations in the Downstream and Drug Product areas in a timely and conclusive manner. The Principal Engineer frequently resolves complex problems with some precedent and occasionally unprecedented problems using experience and the efficient application of scientific methodology and technical reasoning. This position performs comprehensive data analysis of Downstream and Drug Product process statistics independently, identifies process deviations, prepares technical reports and proposes comprehensive process solutions and improvements. The Principal Engineer communicates investigation outcomes effectively to regulatory agencies, BI senior management and customers as SME.
+ This position participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies. Provides comprehensive training and guidance to other scientists.
+ This position frequently leads and executes initial facility fit subtasks and occasionally leads overall initial facility fit assessments for the Downstream and Drug Product portions of the GMP Manufacturing facilities.
+ This position identifies and proposes improvements for Downstream and Drug Product manufacturing processes. Frequently leads and executes complex process and procedural changes to improve process performance, robustness, productivity, safety and efficiency. The position generates unique and innovative contributions to the BIFI site to improve overall site performance and contributes to product quality and regulatory as SME.
+ This position plans and executes continuous improvement in innovation and technology and a stronger IP position for BI. Leads implementation of state-of-the-art technologies for Downstream and Drug Product MSAT and facility/production equipment modifications needed to maintain state-of-the-art production. Works cross functionally and with other BI sites to ensure changes are truly state-of-the-art, integrate well into BI systems and to ensure that best practices are shared.
+ This position frequently plans and executes and occasionally designs and optimizes Downstream and Drug Product manufacturing facility expansion and modification to support current and future Downstream and Drug Product process requirements.
Requirements
+ At least Bachelor’s degree from an accredited institution with ten plus (10+) years’ experience OR Master’s degree from an accredited institution with nine plus (9+) years’ experience OR PhD from an accredited institution with two plus (2+) years of industry experience and statistical analysis skills
+ One (1) to three (3) years leadership and project management experience
+ Technical knowledge in process science area
+ Technical knowledge of purification/aseptic manufacturing principles, techniques and equipment
+ Technical knowledge of primary and secondary packaging components and equipment
+ Understanding of validation of biopharmaceutical facilities, equipment and process
+ Drives continuous process improvements
+ Ability to lead effectively in a matrixed organization
+ Proven skills building and maintaining productive relationships with organizational partners such as manufacturing and quality
+ This position is accountable to answer process related questions of regulators. The position must have expert knowledge of Downstream and/or drug product processes and related manufacturing equipment and facility attributes for the BIFI site. The position interacts with regulators in a manner consistent with BI training and guidance and the position must exemplify BI values in these interactions.
Desired Skills, Experience and Abilities
+ Six Sigma experiences will be a plus
+ Experience/Expertise in a scientific discipline (chemical/biochemical engineering, biopharmaceuticals, biotechnology, molecular biology, biochemistry, cell biology)
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.
Compensation Data: This position offers a base salary typically between $112,000 and $193,000 annually. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.
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.
The primary purpose of the position is to lead and manage several projects within the Downstream (DS) and Drug Product (DP) Manufacturing Science and Technology (MSAT) group. The Principal Engineer frequently solves complex problems with some precedent and occasionally unprecedented complex scientific and manufacturing problems based on experience and scientific and engineering knowledge. Leadership includes leading teams, coaching and mentoring junior staff, driving initiates to increase efficiency and the robustness of operations and promoting effective cross functional communications and collaborations. The Principal Engineer must provide technical and scientific expertise to specific areas of responsibility of the DS and DP MSAT group. The position holder must be an effective representative of BIFI and BI in interactions with regulators and high level customers as Subject Matter Expert (SME). The Principal Engineer must live the BI values and promote a positive work environment for others. The position supports and occasionally leads Initial Facility Fits into the DS and DP GMP manufacturing areas. The Principal Engineer ensures that conclusions reached and recommendations made are scientifically defensible and adhere to all Quality standards, executes against deliverables developed by the department leadership, and creates proposals to improve operational efficiency. The Principal Engineer regularly serves as Process Science representative on project teams. This position may lead New Product Introduction and GMP operation in the Disposables Clinical Manufacturing Facility to produce drug substance under GMP/GLP conditions for toxicology and clinical studies. 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 Ingelheim's high regard for our employees
Duties & Responsibilities
+ This position plans and executes complex scale-up and characterization activities of Downstream and Drug Product manufacturing processes in a robust and scientific manner leading to predictable process performance and a well characterized process. The Principal Engineer utilizes scale-up experience, facility specific knowledge, and engineering principals to introduce new processes into Manufacturing and consistently deliver the expected process performance across all new products.
+ The position develops and executes plans independently to determine root cause of process related deviations in the Downstream and Drug Product areas in a timely and conclusive manner. The Principal Engineer frequently resolves complex problems with some precedent and occasionally unprecedented problems using experience and the efficient application of scientific methodology and technical reasoning. This position performs comprehensive data analysis of Downstream and Drug Product process statistics independently, identifies process deviations, prepares technical reports and proposes comprehensive process solutions and improvements. The Principal Engineer communicates investigation outcomes effectively to regulatory agencies, BI senior management and customers as SME.
+ This position participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies. Provides comprehensive training and guidance to other scientists.
+ This position frequently leads and executes initial facility fit subtasks and occasionally leads overall initial facility fit assessments for the Downstream and Drug Product portions of the GMP Manufacturing facilities.
+ This position identifies and proposes improvements for Downstream and Drug Product manufacturing processes. Frequently leads and executes complex process and procedural changes to improve process performance, robustness, productivity, safety and efficiency. The position generates unique and innovative contributions to the BIFI site to improve overall site performance and contributes to product quality and regulatory as SME.
+ This position plans and executes continuous improvement in innovation and technology and a stronger IP position for BI. Leads implementation of state-of-the-art technologies for Downstream and Drug Product MSAT and facility/production equipment modifications needed to maintain state-of-the-art production. Works cross functionally and with other BI sites to ensure changes are truly state-of-the-art, integrate well into BI systems and to ensure that best practices are shared.
+ This position frequently plans and executes and occasionally designs and optimizes Downstream and Drug Product manufacturing facility expansion and modification to support current and future Downstream and Drug Product process requirements.
Requirements
+ At least Bachelor’s degree from an accredited institution with ten plus (10+) years’ experience OR Master’s degree from an accredited institution with nine plus (9+) years’ experience OR PhD from an accredited institution with two plus (2+) years of industry experience and statistical analysis skills
+ One (1) to three (3) years leadership and project management experience
+ Technical knowledge in process science area
+ Technical knowledge of purification/aseptic manufacturing principles, techniques and equipment
+ Technical knowledge of primary and secondary packaging components and equipment
+ Understanding of validation of biopharmaceutical facilities, equipment and process
+ Drives continuous process improvements
+ Ability to lead effectively in a matrixed organization
+ Proven skills building and maintaining productive relationships with organizational partners such as manufacturing and quality
+ This position is accountable to answer process related questions of regulators. The position must have expert knowledge of Downstream and/or drug product processes and related manufacturing equipment and facility attributes for the BIFI site. The position interacts with regulators in a manner consistent with BI training and guidance and the position must exemplify BI values in these interactions.
Desired Skills, Experience and Abilities
+ Six Sigma experiences will be a plus
+ Experience/Expertise in a scientific discipline (chemical/biochemical engineering, biopharmaceuticals, biotechnology, molecular biology, biochemistry, cell biology)
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.
Compensation Data: This position offers a base salary typically between $112,000 and $193,000 annually. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.
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