Manufacturing Process Engineer

Wedgewood Pharmacy LLC; San Jose (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Join an innovative company dedicated to enhancing veterinary care through advanced compounded medications. As a key member of the engineering team, you will design and develop manufacturing processes that improve productivity and product quality. This role offers a dynamic work environment where your skills in technical troubleshooting and regulatory compliance will be crucial. You'll be part of a team that values collaboration and promotes from within, ensuring your growth and success in the industry. With a comprehensive benefits package and a commitment to diversity, this opportunity is perfect for those looking to make a difference in animal health.

Benefits

Health Insurance

Dental Insurance

401(k) Retirement Plan

Paid Time Off

Company Paid Life Insurance

Flexible Spending Accounts

Voluntary Insurance Options

Qualifications

• Comprehensive knowledge of cGMP guidelines and regulatory compliance.
• Ability to generate cGMP documents like Deviation and CAPA.

Responsibilities

• Provide maintenance improvement support for facility machinery.
• Drive lean manufacturing activities and project management.
• Ensure compliance with FDA regulations and GMP standards.

Skills

Technical Troubleshooting

Lean Manufacturing

Project Management

Regulatory Compliance

cGMP Documentation

Education

Bachelor's in Mechanical Engineering

Bachelor's in Chemical Engineering

Bachelor's in Electronic/Electrical Engineering

Bachelor's in Automation

Job description

This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. This position will provide manufacturing/sustaining support in the production of Wedgewood Connect products.

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:

• Provide maintenance improvement support for facility machinery and mechanical equipment such as autoclaves, air handling units, tablet machines, refrigerators/freezers, water purification systems, and various production equipment
• Drive lean manufacturing activities and project management in strategic focus areas
• Assist and support the design of processes, tools, and methods necessary to establish, introduce, or transfer products into manufacturing in the most effective way using lean analysis
• Lead Capital Equipment/Systems projects while also providing value as an individual contributor
• Complete commissioning and qualification project plans, protocols, and reports in alignment with GMP regulations, industry standards, and Company policies
• Strong technical troubleshooting skills and the ability to generate various types of cGMP documents such as Deviation, CAPA, Out Of Specification (OOS), and validation protocols/final reports
• Ensure compliance with safety and emergency preparedness plans
• Ensure GMP compliance in coordination with Document Control, R&D, and Quality Assurance functions (SOPs, SMVP, IQ/OQ/PQs, etc.)
• Ensure Compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Performs other related duties and responsibilities as assigned
• Occasionally, the employee will be required to lift or move at least 40 pounds.

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

What you’ve done:

• BSc or MSc in Mechanical Engineering, Chemical Engineering, Electronic/Electrical Engineering, or Automation, or equivalent experience
• Minimum of 2-5 years of relevant engineering experience required
• Experience with cGMP, pharmaceutical cGMP a plus

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
• 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.

Qualifications

Education

Required

Bachelors or better in Engineering or related field.

Experience

Required

2-5 years:

2-5 years:

technical troubleshooting

2-5 years:

2-5 years:

SOPs, SMVP, IQ/OQ/PQs

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.