Manufacturing Engineering Technician

Curia • Albuquerque, NM

5h • Onsite

About The Position

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.

Requirements

• High school diploma or general education degree (GED)
• Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills, along with effective presentation skills.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
• Strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
• Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• Ability to cultivate a culture of continuous improvement and right first-time quality
• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• Must be able to obtain and maintain gowning certification
• Must be able to obtain and maintain media qualification
• Must be able to wear a respirator

Nice To Haves

• 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

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED