Overview

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, OhioJob Type: Full TimeSchedule: 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, a