Manufacturing Technician

McGuff Pharmaceuticals, Inc.; Santa Ana (CA); On-site; USD 52,000 - 64,000; Full time

Job summary

McGuff Pharmaceuticals, Inc. is seeking a Manufacturing Technician to develop and maintain production and maintenance activities, supporting various operations as assigned. The role emphasizes following procedures, cleaning, and maintaining aseptic equipment.

Responsibilities include performing phase-based duties, ensuring clean room standards, and assisting Engineering and QA teams. The technician must be able to handle physical tasks and adhere to safety guidelines in a fast-paced

Qualifications

• Read, comprehend, and execute procedures as written.
• Perform facility cleaning, sanitation, and pest control including clean room disinfection.
• Maintain and operate pharmaceutical manufacturing equipment and auxiliary systems.
• Assist Engineering, QA and on-site laboratories on projects as assigned.

Responsibilities

• Read, comprehend, and execute procedures as written.
• Clean, sanitize, and disinfect facilities and clean rooms.
• Maintain and clean manufacturing equipment (aseptic fill lines, washers, ovens, autoclave, cooling systems).
• Support maintenance and monitoring of facility and equipment to ensure operations.
• Assist Engineering, QA and on-site labs on projects as assigned.
• Ensure customer needs are satisfied and provide help where needed.
• Other varied duties as assigned.
• Maintain qualification as Aseptic Fill Operator for manual and automated processes.

Job description

The Manufacturing Technician, will develop and maintain assigned elements of production/maintenance activities and associated procedures as well as provide support to various other operations as assigned.

Duties shall include:

Phase (level) 1:

• 1. Read, comprehend, and execute procedures as written.
• 2. Facility cleaning, sanitation, and pest control including critical cleaning and disinfection of Clean Room areas
• 3. Maintenance and cleaning of pharmaceutical manufacturing equipment including, but not limited to, automated aseptic fill lines, washers, ovens, autoclave, cooling systems and WFI/Pure Steam generator.
• 4. General maintenance and monitoring activities of facility and equipment as required by McGuff management and procedures to ensure ongoing operations
• 7. Assisting Engineering, QA and the on-sight laboratories in various projects as assigned
• 8. Assure the customer’s needs are satisfied and help out wherever is needed.
• 9. Other varied duties as assigned.

Phase (level) 2:

• 1. All job duties as indicated in the job description for the Manufacturing Technician, Phase 1.
• 2. Pass and maintain individual qualification as an Aseptic Fill Operator for manual and automated Aseptic fill processes per McGuff policies and procedures.
• 3. Maintain qualification as an Aseptic Fill Operator for manual and automated Aseptic fill processes for at least six months.
• 4. Perform Main Operator and Assistant duties during automated aseptic fill processes, as assigned.
• 5. Guide, assist in training and counsel other technicians to accomplish training and operational goals.
• 6. Other varied duties as assigned.

Phase (level) 3:

• 1. All job duties as indicated in the job description for the Manufacturing/Production Technician, Phase 1 and 2.
• 2. Perform equipment troubleshooting, evaluation and repairs as directed by Facilities and Engineering personnel.The Phase 3 technician will demonstrate a proficient knowledge of at least two (2) equipment systems to enable timely and effective troubleshooting and repair for operational needs.
• 3. Achieve and demonstrate capabilities to perform critical, aseptic machine set-up and tear down procedures for aseptic fill lines and ancillary equipment.
• 4. Guide, train and counsel other level 1, 2 and 3 technicians to accomplish training and operational goals.
• 5. Other varied duties as assigned

2. Physical Requirements:

The position requires bending, squatting, climbing, and reaching above shoulder level.In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).The position will require repetitively lifting/carrying up to 75 pounds and manipulating upwards of 200 lb.

The job will require the Technician to properly don and wear personnel protective equipment including but not limited to specified respirators and masks, Powered Air Purifying Respirators (PAPR), eye protection, and protective gowns/jumpsuits and/or Racal Suits.

• a. Knowledge and effective implementation of job duties
• c. Knowledge, understanding and compliance of the dress code
• d. Ability to work with others
• e. Adequate communication skills
• f. Ability to communicate, assist and counsel other manufacturing technicians to meet training and operational goals.