Master Associate, DS Plant Engineering

Master Associate, DS Plant Engineering

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Description:

Description\:

The Master Associate assists in ensuring process equipment readiness in BI Fremont's GMP manufacturing facility for the manufacture of biopharmaceutical drug substance. This includes assisting the troubleshooting and identification of potential improvements in mechanical and automation functionalities of production equipment in order to maintain reliable operations of critical GMP manufacturing process equipment in accordance to the qualification capabilities and GMP requirements. Assists in the execution of CAPAs and ongoing validation and provide technical input for CAPEX projects.

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\:

• 
  Assists in the identification of new manufacturing equipment or modifications to optimize existing processes and ensure achievement of regulatory and safety requirements.
  
  Assists with the pre-production readiness program with regard to wet run checklists, equipment checklist, tracking the use of assets in collaboration with area owners.
• Assists with technical troubleshooting of mechanical and automation issues. Assist in the implementation new or adjusted solutions to increase the reliability and availability of equipment in the assigned department.
• Assist in the execution of at scale process studies, i.e. mixing studies, media hold studies, to support process improvements and equipment validation.
• Assist in the execution of CAPAs with regard to process equipment operations and on-going validation.
• Provide technical input for CAPEX projects as user engineers.
• Ensures compliance with manufacturing processes in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives. Demonstrates good knowledge of GMP, FDA and European regulations.
  
  Follow all relevant department policies, procedures, SOP and other requirements and act at all times within the BI standards/ethics policies
  

Requirements\:

• 
  High School degree with a minimum of four (4) years of work experience in GMP regulated industry; Or
• Associates or Bachelors degree from an accredited institution, or biotechnology vocational training preferred, and a minimum of two (2) years of work experience in GMP regulated industry.
• Subject Matter Expert of biopharmaceutical manufacturing equipment and operations, as well as a high technical knowledge of biologics principles required. Independently troubleshoot GMP process equipment failures by gathering data, analyzing data and cross functionally cooperate to implement solutions.
• Must be able to demonstrate basic understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation
• Understanding of facility technology, system troubleshooting using root cause analysis tools, CAPA's and change controls highly preferred
• Must have strong communication skills to communicate and oversee equipment modifications in conjunction with our maintenance staff
  

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.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

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, 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.