Wedgewood Pharmacy
Manufacturing Process Engineer
Albany, OH · Full-time
Sponsorship not specified$90k-$125kDetected 28 days ago
BudgetingGMPFDA RegulatoryProblem SolvingAdaptability
About the role
- Every role in our organization contributes to helping pets live healthier, happier lives.
- Our Commitment to Inclusion Wedgewood Pharmacy is an equal opportunity employer.
Responsibilities
- Design, develop, and implement manufacturing processes, tooling, and workflows to support sterile compounding and production scale-up
- 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
- 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
Requirements
- 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
- 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
- Ability to work cross-functionally and adapt in a growing environment
- Strong attention to detail and ability to thrive in a fast-paced environment
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
- Compensation: The base pay range for this position is $90K-$125K base plus an annual bonus commensurate with the individual's experience and qualifications.
Company info
- What We're Looking For
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