Manufacturing Engineering Technician

Manufacturing Engineering Technician

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer:

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Summary:

The Manufacturing Engineering Technician provides technical and operational support for the manufacture of sterile parenteral products in a controlled and aseptic environment. This role supports manufacturing operations by ensuring compliance with current Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements while promoting safe, efficient, and compliant production activities. The Manufacturing Engineering Technician partners closely with Manufacturing Engineering, Quality, and Operations personnel to support equipment readiness, manufacturing processes, troubleshooting efforts, personnel development, and continuous improvement initiatives.

This position requires strong technical aptitude, attention to detail, and the ability to maintain a consistent presence within manufacturing operations to support business needs.

Essential Duties and Responsibilities:

• Serve as the process lead within assigned manufacturing areas, providing technical guidance and ensuring manufacturing activities are executed safely, compliantly, and in accordance with approved procedures.
• Support manufacturing operations involving vial preparation, isolator operations, aseptic filling, and vial sealing activities.
• Assist in meeting production schedules and manufacturing objectives through effective execution and coordination of assigned operational activities.
• Partner with Manufacturing Engineers to support manufacturing operations, equipment performance, process improvements, and issue resolution.
• Identify and resolve manufacturing process issues through collaboration with Quality, Engineering, and Technical Operations personnel.
• Manage assigned areas of responsibility by ensuring compliance with current Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements while maintaining a controlled aseptic manufacturing environment.
• Ensure compliance with Drug Enforcement Administration (DEA) regulations during controlled substance manufacturing activities and verify adherence to applicable requirements.
• Provide process-specific training and technical instruction on equipment setup, operation, sanitization, sterilization, aseptic techniques, and cleanroom manufacturing practices.
• Manage the preparation, assembly, disassembly, cleaning, sanitization, and sterilization of equipment used in cleanroom, compounding, and filling operations in accordance with approved procedures and production schedules.
• Perform and oversee the sanitization of aseptic and controlled manufacturing areas using approved disinfectants, cleaning agents, equipment, and procedures to reduce microbial contamination to acceptable levels.
• Follow sanitization protocols during sterile processing activities and ensure manufacturing areas and equipment are maintained in a state of cleanliness and readiness for production.
• Review manufacturing documentation, logbooks, and batch records for accuracy, completeness, and compliance with current Good Documentation Practices (cGDP).
• Maintain accurate and complete documentation associated with manufacturing, sanitization, sterilization, and production activities in accordance with cGDP requirements.
• Read, interpret, and comply with Standard Operating Procedures (SOPs), work instructions, batch records, and other controlled documentation to ensure compliance with cGMP requirements.
• Escalate operational, quality, safety, equipment, and compliance concerns to manufacturing supervision in a timely manner.
• Participate in training and continuous improvement initiatives to enhance manufacturing processes, productivity, quality, compliance, and operational efficiency.
• Maintain qualification requirements, including gown qualification and validation for Grade A aseptic manufacturing environments.
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and/or

Experience:

• High school diploma or general education degree (GED)
• Associate's Degree in Engineering, Engineering Technology, or related discipline, preferred
• Two (2) years prior experience in a fill/finish GMP and/or cleanroom, preferred

Supervisory Responsibilities:

This role does not have supervisory responsibilities, yet it may involve being a lead person for operations and…