Manufacturing Process Engineer

Job description

At Wedgewood Pharmacy, we are dedicated to improving the lives of animals through customized medication and compassionate care. Every role in our organization contributes to helping pets live healthier, happier lives. We are a team driven by purpose, quality, and a shared commitment to animal health. 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 **Why We Do What We Do** At Wedgewood Pharmacy, your work has purpose. Every prescription you help prepare, support, or deliver contributes to improving the health and well-being of animals. We are passionate about what we do and proud to build a workplace where people feel supported, included, and valued. **Our Commitment to Inclusion** Wedgewood Pharmacy is an equal opportunity employer. We are committed to building a diverse and inclusive workplace where everyone can thrive.