Manufacturing Process Engineer

Manufacturing Process EngineerAt 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 BasicsLocation: 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: EligibleHow You'll Make an ImpactDesign, develop, and implement manufacturing processes, tooling, and workflows to support sterile compounding and production scale-upTroubleshoot process, equipment, and facility issues in real time to minimize downtime and ensure production continuityLead facility startup activities, including equipment installation, commissioning, qualification (IQ/OQ/PQ), and validationBuild and refine manufacturing systems, documentation, and processes from the ground up in a fast-paced environmentPartner cross-functionally with Quality, Operations, and R&D to ensure compliance with U.S. Food and Drug Administration 503B outsourcing facility requirements and cGMP standardsAuthor and maintain cGMP documentation including SOPs, batch records, validation protocols, and technical reportsDevelop and implement Preventive Maintenance and Calibration programs for critical manufacturing and facility equipmentProvide engineering support for critical systems, including:Autoclaves and sterilization equipmentCleanroom and HVAC & Water systems (e.g., WFI, purified water)Refrigeration and controlled storage systemsFilling, compounding, and packaging equipmentDrive root cause investigations, deviations, and CAPAs to ensure sustainable process improvementsSupport technology transfer and scale-up of new products into manufacturingEvaluate and implement process improvements to increase throughput, reduce waste, and enhance product qualityManage capital projects, including vendor selection, budgeting, and executionOperate with a high sense of urgency and adaptability in a startup environment with evolving prioritiesWhat We're Looking ForAbility to travel up to 10-15% dependent on business needsBachelor's degree in Engineering, Life Sciences, or related technical field1–5+ years of experience in manufacturing, engineering, or a regulated environment (internships/co-ops considered)Practical hands on experience with solid oral dose manufacturingBasic understanding of cGMP or regulated industry practicesStrong troubleshooting and problem-solving skillsYou 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 environmentThrive in a fast-paced environment and adapt to changing prioritiesDetail-oriented individual who understands the importance of accuracy and responsivenessAbility to work cross-functionally and adapt in a growing environmentStrong attention to detail and ability to thrive in a fast-paced environmentCollaborative mindset and commitment to team successWhat You'll Love About WedgewoodOpportunities for growth and career developmentA supportive, team-first culture where your work mattersThe ability to make a real impact on animal health every dayA comprehensive benefits package that includes health, dental, and flexible spending accounts401(k) retirement plan with a generous company contribution to help you save for the futureCompany Paid Life and disability insuranceAccess to voluntary insurance optionsA generous paid time off program that increases every yearTuition reimbursementWhy We Do What We DoAt 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 InclusionWedgewood Pharmacy is an equal opportunity employer. We are committed to building a diverse and inclusive workplace where everyone can thrive.