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.

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