Associate/Senior Process Engineer Downstream

Description

The Associate Process Engineer - Downstream is responsible to provide technical support for routine operations and to support the transfer and implementation of new processes into BI Fremont's GMP facility for the manufacture of biopharmaceutical drug substance. This includes process transfers of internal BI products and external contract manufacturing business (CMB) client products into the multi-product facility. This position provides scientific and technological support during process transfers, launch, and initial supply, including troubleshooting and continuous process improvements in a highly complex environment. This role acts as the technical interface between at-scale manufacturing and the customer (&/or Process Sciences) within a cross-functional project organization and supports deliverables with GMP/regulatory requirements. This role is expected to require close supervision and support from senior PE's and area management. 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.

The primary purpose of the Sr. Engineer is to manage project, perform experiments and analyze data in the Downstream (DS) and Drug Product (DP) Manufacturing Science and Technology (MSAT) group. The Senior 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 MSAT in interactions with customers and collaborators internal and external. The Senior Engineer must live the BI values and promote a positive work environment for others. The Senior Engineer frequently leads the design and execution of complex experiments with sound scientific and engineering principals to resolve problems, recognizes and resolves unprecedented problems under minimum guidance and frequently executes against specific deliverables developed by the department leadership. The Senior Engineer creates proposals to improve operational efficiency. The Senior Engineer occasionally serves as Process Science representative on project teams. This position may lead New Product Introduction and GMP operations 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

Associate Engineer

• Responsible to provide technical support for process troubleshooting, process/tech transfers and continuous improvement efforts.
• Applies technical knowledge of at-scale manufacturing assigned unit operations/processes of moderate complexity, with oversight from senior team members, inclusive of liquid chromatography, column packing, tangential flow and normal flow filtration, bulk formulation and filling, freezing, aseptic processing, buffer preparation and storage, benchtop in-process analytics.
• Follows direction and strategy to support planning and assist in executing support activities, collaborating as an at-scale technical process SME with internal units and external clients to meet project timelines, quality requirements and to identify/mitigate risks as needed.
• Assists with evaluating process requirements/facility-fit assessments including identification of materials/quantities and ensuring that processes are consistent with standard manufacturing practices, policies and regulatory requirements.
• Applies technical knowledge to identify and implement at-scale manufacturing technology improvements with oversight from senior team members and supervisor. Will engage in best-practice networking forums to maintain and/or improve competitive advantage in bio-pharmaceutical manufacturing.
• Contribute to the design and planning of small-scale studies in collaboration with Process Sciences for transfer to or continuous improvement of at-scale manufacturing.
• Responsible for processes and unit operations of moderate complexity and will often leverage the expertise of senior team members and their supervisor.

Sr. Engineer

• Executes and occasionally plans the robust scale-up and implementation of new Downstream manufacturing processes and equipment by performing process design reviews and experimentation on specific aspects of the process. The Senior Engineer utilizes scale-up experience, facility specific knowledge and engineering principals to trouble shoot equipment and processes; anticipate potential problems and propose risk mitigations and proactive solutions.
• Executes and develops plans independently to determine the root cause of process related deviations in the Downstream areas in a timely and conclusive manner. Works with the MSAT team to resolve complex problems and deviations using experience and efficient application of scientific methodology and technical reasoning. Designs and executes complex experiments to resolve specific deviation questions, prepares technical reports and proposes comprehensive process solutions and improvements.
• Effectively communicates investigational designs, results and recommendations to internal teams and customers.
• 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.
• Frequently executes and occasionally leads Initial Facility Fit assessment subtasks for the Downstream and Drug Product portions of the GMP Manufacturing facilities.
• Identifies and proposes continuous process improvements to management and frequently executes and occasionally leads complex process and procedural changes to improve Downstream and Drug Product manufacturing process performance, robustness, productivity, safety and efficiency.
• Executes and occasionally develops plans for continuous improvement in innovation and technology and contributes to a stronger IP position.

Requirements

Associate Engineer

• Bachelors Degree from an accredited institution in Bio/chemical Engineering (or related field) with zero to three (0-3) years of professional experience or four-plus (4+) years of demonstrating equivalent technical/design experience in large scale bio-pharmaceutical manufacturing.
• Experience working in cross-functional teams
• Experience with downstream bio-pharmaceutical manufacturing
• Experience with biopharmaceutical manufacturing processes and technical writing is a plus
• Demonstrated aptitude and drive necessary to implement innovative solutions to complex problems using the best available technology with a reasonable level of input and guidance from their supervisor
• Demonstrated familiarity with fundamental engineering concepts pertaining to fluid dynamics and heat transfer
• An excellent mechanical aptitude
• Ability to organize and multi-task
• Competency with MS Office Programs
• Good communication skills
• Ability to work in a team setting as well as an individual contributor
• Ability to work cross functionally in a dynamic, high pressure environment
• Hybrid remote/on-site working environment

Sr. Engineer

• At least Bachelor's degree from an accredited institution with five plus (5+) years' experience OR Master's degree from an accredited institution with three plus (3+) years' experience OR PhD from an accredited institution with zero (0) years of industry experience and statistical analysis skills
• Project management experience
• Technical knowledge in process science area
• Technical knowledge of downstream/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 may be 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.

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)

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