Manufacturing Engineering Technician

About the role

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.

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.
• Aid 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.
• 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

Requirements

• 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 manufacturing, mentoring, guiding, and advising.

Qualifications

• Strong technical aptitude
• Attention to detail
• The ability to maintain a consistent presence within manufacturing operations to support business needs

Skills

• Technical aptitude
• Attention to detail
• Ability to maintain a consistent presence within manufacturing operations to support business needs

Benefits

Generous benefit options (eligible first day of employment)