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Associate Quality Engineer

Company: CTI Education Group
Location: Fremont
Posted on: May 3, 2021

Job Description:

Job Description - Associate Quality Engineer (214751) Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities. Associate Quality Engineer - 214751 Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations. We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs. Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim's unique experience of having brought 30+ biologics to market globally. Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future. Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients! # LI-MS1 *I-SF1 #PDN1 Description: The Quality Engineer delivers validation of biopharmaceutical manufacturing equipment, utilities, computer systems and laboratory instruments and ensures the Engineering and Technology (E&T) department maintains and continuously improves its state of GMP compliance.They will be responsible for performing qualification and validation activities in a multi-product biotech manufacturing facility and owning records (deviations, CAPAs, Change Control) within the quality systems. The BIFI Quality Engineer will develop risk assessments, validation plans, protocols, and reports that support the qualification and validation of systems. This individual will be responsible for independently developingsimple protocols for small size validation projects using a risk-based approach that meets current regulatory requirements and industry practices.They will review and interpret data for accuracy of system performance for completed validations/revalidations, and prepare final report packages by analyzing and summarizing the data. Additionally, the BIFI Quality engineer will own Quality System records, investigate deviations, write investigation reports, and create and own CAPAs and change controls. This individual will assist in internal, customer and regulatory audits by preparing documentation associated with GMP Systems and processes. 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: Participate in small size validation (Equipment) projects: Participate with risk assessments for new systems and changes to existing systems Write simple validation plans, protocols and reports Owning Quality Systems Records: Create, own, and manage life cycle of minor deviations, corrective actions and change controls for GMP equipment, facilities and automation systems Operate within the relevant quality computer systems (ex. SAP, TrackWise) ensuring implementation in line with quality and timeliness objectives Working closely with Engineering, Quality, Process Development, Validation, and Manufacturing to investigate and resolve deviations including leading investigation teams in order to determine root cause, product impact, and appropriates corrective and preventive actions Preparing material for internal and external regulatory and customer auditors Participate in generating quality system metrics for the E&T department Requirements: Bachelors Degree from an accredited institution in Engineering with one (1) year of relevant cGMP biopharmaceutical manufacturing environment experience, or Masters Degree from an accredited institution in Engineering Working knowledge of GMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements Excellent technical writing and verbal communication skills Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company. Demonstrated ability to manage multiple activities while maintaining a high level of organization Preferred experienced in Microsoft Office Suite Knowledge of Microsoft Excel Good knowledge and skills in biopharmaceutical and process engineering Participation on technical projects with an interdisciplinary project team from planning to realization and start up Understanding of validation concepts for biopharmaceutical manufacturing process, instrumentation and utility equipment. 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 Who We Are: """"""" At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance.We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture.Learning and development for all employees is key because your growth is our growth. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race; 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. Job - Engineering/Facility Management/Infrastructure

Keywords: CTI Education Group, Fremont , Associate Quality Engineer, Other , Fremont, California

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