Bio Process Specialist

Posted 3 Days Ago
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Fort Dodge, IA
Entry level
Healthtech • Pharmaceutical • Manufacturing
The Role
The Bio Process Associate supports manufacturing compliance and process technology for vaccine production, ensuring accurate documentation and adherence to regulatory standards.
Summary Generated by Built In

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Bio Process Specialist

Bio Process Specialist in the Elanco Technical Services & Manufacturing Sciences (TS/MS) team play a vital role in manufacturing compliance, process support, and technology transfer of a diverse portfolio of vaccine products at a company that values inclusion and ownership through accountability. This position is part of a team of  specialists and scientists responsible for creating excellence in manufacturing process technology. You will be accountable for enhancing understanding of the scientific principles that underscore the manufacturing processes and capabilities, and to leverage this to solve complex challenges.

Your Responsibilities:

  • Creates, coordinates, and tracks Process Flow Documents (PFDs), including technical documents, process flow charts, and manufacturing/regulatory data analysis.

  • Interacts with various departments (TS/MS, Engineering, Manufacturing, Regulatory Affairs) to ensure accuracy, address revisions, and seek guidance on compliance.

  • Reviews technical data, identifies compliance gaps, escalates issues, and assists with remediation and change management. Owns process-related events, corrective actions, and changes.

  • Evaluates the appropriateness of regulated manufacturing processes and associated technical documents, including on-site observation. Prepares protocols and technical reports as needed.

  • Aligns technical work with corporate strategy to support product innovation, portfolio expansion, and productivity.

What You Need to Succeed (Minimum Qualifications):

  • Minimum of B.S. in a relevant scientific discipline.

  • Ability to understand purpose and science of manufacturing processes.

  • Ability to follow written procedures, SOPs, and other documents.

What Will Give You the Competitive Edge (Preferred Qualifications):

  • Work experience in USDA or regulated animal health industry is beneficial.

  • Intermediate level understanding or exposure to manufacture of biological products.

  • Attention to detail and commitment to customer service.

Additional Information:

  • Primary work hours are first shift. Occasionally may work non-standard hours dependent on manufacturing process needs.

  • May require gowning into the manufacturing environment.

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! 

Elanco Benefits and Perks: 

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: 

  • Multiple relocation packages for eligible roles

  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 

  • 8-week parental leave 

  • 9 Employee Resource Groups 

  • Annual bonus offering 

  • Up to 6% 401K matching 

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Top Skills

Manufacturing Processes
Process Flow Documents
Regulatory Affairs
Technical Documents
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The Company
HQ: Greenfield, Indianna
8,445 Employees
On-site Workplace

What We Do

At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives.

Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society.

Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco

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