Manufacturing Engineer

About Sani Sure

Sani Sure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today’s most innovative and life-changing medicines.

As we continue to expand our product offerings and global footprint, Sani Sure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.

The Manufacturing Engineer works closely with Operations, Quality, R&D, and cross-functional teams to lead process engineering, continuous improvement, and new product introduction (NPI) manufacturing readiness efforts. This role serves as the technical focal point for manufacturing processes, applying Lean Six Sigma methodologies, statistical tools, and structured problem‑solving to optimize production efficiency, reduce waste, ensure regulatory compliance, and drive measurable improvements across the manufacturing floor.

The Manufacturing Engineer is responsible for process development, validation, documentation, and sustaining engineering activities in support of existing and new products in a GMP medical device environment.

• Develop, own, and maintain Process Failure Mode and Effects Analysis (pFMEA) and Control Plans to proactively identify and mitigate process risks throughout the product lifecycle.
• Lead and execute process qualification activities including IQ, OQ, and PQ protocols.
• Plan and conduct validation runs and Gage R&R studies to ensure measurement system and process capability.
• Support driving BOM creation, product drawings, engineering change control and dimensional inspection criteria.
• Lead root cause and corrective action (RCCA) investigations using structured methodologies (e.g., fishbone diagrams, 5-Whys); author and close CAPAs and NCRs in compliance with regulatory requirements.
• Develop and maintain process flow diagrams, SOPs, and work instructions; ensure all process documentation is accurate, current, and aligned with GMP standards and applicable regulatory requirements.
• Support NPI manufacturing readiness activities including process development, process flow design, costing structure, and capacity modeling to ensure a successful production ramp.
• Evaluate and improve quality control processes; analyze production data and SPC charts, assess process capability (Cpk), and provide management with data‑driven reports and statistical summaries to support informed decision-making.
• Analyze and optimize workflow, equipment placement, and space requirements to improve manufacturing efficiency; conduct time studies and process analyses to identify bottlenecks and implement solutions.
• Support design verification testing and perform process verification/validation.
• Review and calculate labor, material, and production costs; develop standard labor‑based costing structures and review production schedules and future capacity requirements to assist management in resource and planning decisions.
• Coordinate and schedule equipment preventative maintenance; ensure manufacturer procedures and service instructions are followed to maintain production equipment in qualified operating conditions.
• Ensure manufacturing processes are in compliance with applicable regulations and industry standards; support internal and external audits and drive remediation efforts as needed.
• Read and interpret 2D and 3D engineering drawings, blueprints, and models to support process design, tooling assessment, and manufacturing feasibility reviews.
• Develop and maintain positive cross‑functional relationships with Operations, Quality, R&D, and other teams; provide process engineering expertise to support product improvements, complaint investigations, and continuous improvement initiatives.
• Perform other duties as assigned.

Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or another related STEM field.

• 5+ years of hands‑on…