Manufacturing Process Engineer
1 day ago
Albany
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