Manufacturing/Production Engineer I

Curia • Albuquerque, NM

9d • Onsite

About The Position

The Manufacturing Engineer plays a critical role within the manufacturing operations team and is assigned to a designated manufacturing shift. This position provides technical leadership and engineering support for the manufacture of sterile parenteral products in a controlled and aseptic environment, ensuring safe, compliant, and efficient operations. The Manufacturing Engineer partners with cross-functional teams to optimize manufacturing processes, improve equipment reliability and performance, resolve technical challenges, and support continuous improvement initiatives. This role requires a strong foundation in engineering principles, including equipment reliability, maintenance strategies, process optimization, and operational excellence, while maintaining a strong presence within manufacturing operations to support business needs.

Requirements

• Bachelor’s Degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, or related discipline
• 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

• One (1) year of experience supporting a manufacturing environment, preferred
• One (1) year of experience in a bio/pharmaceutical manufacturing environment, preferred

Responsibilities

• Provide day-to-day technical and operational leadership for assigned manufacturing shift activities to ensure safety, quality, compliance, and production objectives are achieved
• Lead and support manufacturing operations involving vial preparation, isolator operations, aseptic filling, and vial sealing activities.
• Ensure production schedules and operational requirements are met through effective coordination of manufacturing activities.
• Train personnel on equipment setup, operation, sanitization, sterilization, and manufacturing processes within cleanroom environments.
• Participate in departmental and site training initiatives to maintain technical competency and support employee development.
• Drive activities and resolutions to improve process flow, safety, and overall production efficiency by identifying bottlenecks and fostering a culture of continuous improvement
• Identify and resolve complex manufacturing issues through collaboration with quality, engineering, and technical operations management
• Manages area of responsibility by ensuring compliance with cGMP standards, overseeing the proper operation and maintenance of equipment, and coordinating the sanitation and sterilization processes, as well as to maintain a controlled aseptic environment
• Ensures compliance with Drug Enforcement Administration (DEA) regulations during controlled substance formulations and verifies that staff adheres to these regulations
• Ensures the timely processing and proper execution of deviations, assessments, investigations & CAPA’s
• Manages the preparation and sterilization processes of equipment for clean rooms, product compounding, and filling according to the preparation list, to include disassembly and assembly
• Responsible for checking the recordings entered by employees of all procedures in logbooks as well as confirm complete/correct batch records according to cGDP
• Oversees the staff to complete the sanitization of aseptic/controlled production areas to ensure microbial contamination is reduced to a safe level on inanimate surfaces
• Conduct root cause analysis (RCA) for equipment failures and implement corrective and preventive actions (CAPA) to prevent recurrence
• Collaborate with cross-functional teams including manufacturing, quality assurance, and engineering to identify opportunities for process improvement and implement solutions
• Perform reliability assessments and develop key performance indicators (KPIs) to monitor and track equipment reliability and performance
• Lead reliability improvement projects to enhance equipment uptime, reduce downtime, and increase overall equipment effectiveness (OEE)
• Ensure compliance with regulatory requirements and industry standards related to equipment reliability and maintenance practices
• Provide technical expertise and support to manufacturing operations, troubleshooting complex technical issues as needed
• Stay informed about emerging technologies and industry trends in reliability engineering to identify opportunities for innovation and competitive advantage
• Assure associated documentation (including work orders and ECOs) are effectively and compliantly completed, updated, and maintained.
• Revise SOPs and documents as needed
• 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: Entry Level