Manufacturing Operations Specialist

8 hours ago

Albuquerque, New Mexico, United States Curia Full time
Manufacturing Operations Specialist

**Job Summary:**

We are seeking a highly skilled Manufacturing Operations Specialist to join our team at Curia. As a key member of our operations team, you will be responsible for ensuring the smooth operation of our manufacturing processes, maintaining a clean and safe working environment, and adhering to all relevant regulations and procedures.

**Responsibilities:**

* Deliver production requirements and train operators to set up, operate, sanitize, and sterilize equipment and manufacturing areas in a cleanroom setting.
* Ensure compliance with all relevant regulations and procedures, maintain current good documentation practices (cGDP) for all activities, and participate in training and continuous improvement initiatives to enhance production processes and efficiency.
* Sanitize aseptic and controlled areas using specialized solutions and equipment, following sanitization protocols during sterile processing of equipment, and comply with Standard Operating Procedures (SOPs) for all sanitization and documentation tasks.
* Represent Manufacturing in leadership meetings to support dedicated areas of responsibility, revise SOPs and documents as needed, and identify and resolve complex manufacturing issues through collaboration with quality, engineering, and technical operations management.
* Manage 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.
* Ensure compliance with Drug Enforcement Administration (DEA) regulations during controlled substance formulations and verify that staff adheres to these regulations.
* Manage the preparation and sterilization processes of equipment for clean rooms, product compounding, and filling according to the preparation list, to include disassembly and assembly.
* 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.

**Requirements:**

* Bachelor's Degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, or related discipline.
* Language Skills: ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
* Computer Skills: strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions, including manufacturing and internet software, and proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

**What We Offer:**

* 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.

**Curia is an Equal Opportunity Employer.**

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