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Specialist, Manufacturing – Downstream – Continuous Improvement

Fremont, CA Boehringer Ingelheim

Description:

Description:

 

To manage and/or own continuous improvement initiatives (Green Belt), manage global BI projects, BIFI site initiatives, and BIOS projects within the manufacturing department.

 

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:

  • Actively identify and implement manufacturing procedure improvements intended to optimize existing processes and ensure achievement of regulatory and safety requirements.  Update GMP documentation as required.

  • Ensure work environment meets Boehringer Ingelheim and industry standards. Initiate lean manufacturing techniques in order to actively reduce process and change over cycle times.

  • Identifies areas for Continuous Process Improvement and apply operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.

  • Report findings to management team and team members with recommendations for improvement. Research new methods or steps in a process, present findings, and make recommendations to the team, including developing new and revised Standard Operating Procedures, implementing new equipment and/or developing new processes.

  • Prepare ad hoc reports as requested and maintain/track operational KPIs

  • Applies project management skills and concepts to lead or manage projects with an interdisciplinary project team, and from planning stage to project completion.

Requirements:

  • Requires a High School degree with seven (7) years’ experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.

  • Associate’s degree from an accredited institution plus five (5) years of manufacturing experience in a cGMP pharmaceutical manufacturing environment OR Bachelor’s degree from an accredited institution, preferably in a science or engineering related field plus three (3) years’ experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.

  • Additional competencies include, but are not limited to: stakeholder management, influencing/motivating teams without direct authority, presenting data, performing FMEA & gap assessments, and Lean manufacturing concepts. 

  • Excellent oral communication skills 

  • Must exercise rapid learning ability, attention to detail, excellent computer skills, team player, organized analytical thinker with a high level of energy and self-motivation.  

  • Ability to read, develop and understand procedures and other controlled documents

  • Must have excellent written and verbal communication skills, including technical writing.

  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the manufacturing.

  • Demonstrated proficiency in MS Office programs and associated computer programs

  • Must be able to work in a team environment.

  • Ensures compliance with all manufacturing processes in accordance with Government (cGMP, FDA, DEA, OSHA, and 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 during project execution and act at all times within the BI standards/ethics policies.

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

Our Culture:

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees.  Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.  Since we are privately held, we have the ability to take an innovative, long-term view.   Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families.  Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work.  Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce.  All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

 

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.

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