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.

The Basics

Location: Albany, Ohio
Job Type: Full Time
Schedule: Monday - Friday 8:00 am -4:30 pm (Must have the ability to respond to emergencies and be available for occasional weekend work for special projects)
Compensation: The base pay range for this position is $90K-$125K base plus an annual bonus commensurate with the individual's experience and qualifications.
Benefits: Eligible

How You'll Make an Impact

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

What We're Looking For

Ability to travel up to 10-15% dependent on business needs
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)
Practical hands on experience with solid oral dose manufacturing
Basic understanding of cGMP or regulated industry practices
Strong troubleshooting and problem-solving skills
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
Strong attention to detail and ability to thrive in a fast-paced environment
Collaborative mindset and commitment to team success

What You'll Love About Wedgewood

Opportunities for growth and career development
A supportive, team-first culture where your work matters
The ability to make a real impact on animal health every day
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

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Manufacturing Process Engineer