Manufacturing Process Engineer

The Manufacturing Engineer will play a critical role in building and scaling manufacturing operations. This position is responsible for developing, implementing, and continuously improving manufacturing processes, equipment, and systems to support sterile pharmaceutical production. 

This is a highly hands-on role in a startup environment, requiring the ability to operate both strategically and tactically supporting day-to-day production while establishing scalable, compliant processes aligned with FDA and cGMP requirements. 

When will you work?

• This position will be based in San Jose, CA and will be a salaried level position. Hours will generally be Monday-Friday 8:00 am-4:30 pm, but could shift due to the needs of the site.
• Must have the ability to respond to emergencies and be available for occasional weekend work for special projects.

What you’ll do:

• • Design, develop, and implement manufacturing processes, tooling, and workflows to support sterile compounding and production scale-up  
  • Troubleshoot process, equipment, and facility issues in real time to minimize downtime and ensure production continuity  
  • Lead facility startup activities, including equipment installation, commissioning, qualification (IQ/OQ/PQ), and validation  
  • Build and refine manufacturing systems, documentation, and processes from the ground up in a fast-paced environment  
  • Partner cross-functionally with Quality, Operations, and R&D to ensure compliance with U.S. Food and Drug Administration 503B outsourcing facility requirements and cGMP standards  
  • Author and maintain cGMP documentation including SOPs, batch records, validation protocols, and technical reports  
  • Develop and implement Preventive Maintenance and Calibration programs for critical manufacturing and facility equipment  
  • Provide engineering support for critical systems, including:  
  • Autoclaves and sterilization equipment  
  • Cleanroom and HVAC & Water systems   (e.g., WFI, purified water)
  • Refrigeration and controlled storage systems  
  • Filling, compounding, and packaging equipment  
  • Drive root cause investigations, deviations, and CAPAs to ensure sustainable process improvements  
  • Support technology transfer and scale-up of new products into manufacturing  
  • Evaluate and implement process improvements to increase throughput, reduce waste, and enhance product quality  
  • Manage capital projects, including vendor selection, budgeting, and execution  
  • Operate with a high sense of urgency and adaptability in a startup environment with evolving priorities 
  • Ability to travel up to 10-15% dependent on business needs  

Who you are:

• You bring a positive, professional attitude and can communicate and collaborate with all levels of employees, customers, contractors & vendors.
•  Comprehensive knowledge of Regulatory and cGMP guidelines, with the ability to contribute to quality records (Deviations, Investigations, CAPA, and Change Control).
• Ability to work independently and in a team environment
• Thrive in a fast-paced environment and adapt to changing priorities
• Detail-oriented individual who understands the importance of accuracy and responsiveness
• Ability to work cross-functionally and adapt in a growing environment  

What you’ve done:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field  
• 1-5 years of experience in manufacturing, engineering, or a regulated environment (internships/co-ops considered)  
• Basic understanding of cGMP or regulated industry practices  
• Strong troubleshooting and problem-solving skills  

What’s in it for you:

• A comprehensive benefits package that includes health, dental, and flexible spending accounts
• 401(k) retirement plan with a generous company contribution to help you save for the future
• Company Paid Life and disability insurance
• Access to voluntary insurance options
• A generous paid time off program that increases every year
• Tuition reimbursement
• Opportunity for growth - We believe in promoting from within and do so through our internal job posting program!

About Us

Wedgewood is the nation’s largest and most trusted provider of compounded veterinary medications. Its recent merger with Blue Rabbit enables the company to provide veterinarians with next-generation software to streamline patient care and marks a significant evolution in services. Together Blue Rabbit and Wedgewood serve more than 70,000 veterinary professionals and one million animals annually.

Wedgewood is an equal opportunity employer.  We celebrate diversity and are committed to creating an inclusive environment for all employees.  If you require an accommodation due to a special need or disability, please let your recruiter know what accommodations you will need.