Filling/Formulation Manufacturing Technician

Responsibilities

• Perform routine cleaning and sanitization of production areas to maintain a controlled and compliant environment. 
• Complete training for routine cleaning and sanitization of production areas to maintain a controlled and compliant environment. 
• Prepare and transfer materials and components for production using proper sanitization techniques and aseptic handling practices. 
• Complete training to prepare and transfer materials and components for production using proper sanitization techniques and aseptic handling practices. 
• Utilize proper aseptic techniques in Grade B/C/D and CNC environments during all tasks. 
• Adhere to safety and environmental health standards, including proper use of PPE. 
• Perform Inspection, labeling, and packaging of vials, IV bags, and syringes. 
• Perform dispensing and formulating raw materials for aqueous and non-aqueous products, ensuring accuracy and compliance with batch records. 
• Perform preparation of equipment for use using sterilization equipment such as autoclaves and HEPA cabinets. 
• Operate and maintain equipment used across all production processes, including formulation, filling, sterilization, inspection, and packaging with support and oversight from other Manufacturing team members.  
• Complete all GMP documentation, including batch records, protocols, and deviations, adhering to Good Documentation Practices (GDP). 
• Collaborate cross-functionally with production, QA, QC, engineering, validation, and maintenance teams as required. 
• Recognize and report deviations, potential issues, or equipment malfunctions to the management team. 
• Load, operate, and unload sterilization equipment, such as autoclaves, terminal sterilizer, and HEPA transfer carts. 
• Maintain consistent presence on Manufacturing floor and support all teams in production as needed.  
• Assist with set up and operate filling lines and associated equipment, including mixers, tanks, pumps, autoclaves, and HEPA transfer carts. 
• Assist with troubleshooting equipment breakdowns.

Required Skills and Qualifications

• High School Diploma or equivalent required. An associate degree in a technical field or a bachelor's degree in biological, chemical sciences, or engineering preferred but not required.  
• 1+ years in pharmaceutical manufacturing environments. 
• Mechanical aptitude to operate and troubleshoot a variety of equipment and instruments. 
• Understanding of GMP and GDP standards. 
• Strong attention to detail, with the ability to follow SOPs, complete documentation tasks accurately. 
• Basic computer skills and familiarity with technical documentation. 
• Mathematical skills for measurements and calculations (e.g., volume, weight). 
• Physical ability to raise arms over head, stoop, stand, climb, and lift 30-50 lbs. 
• Effective verbal and written communication skills. 
• Prolonged periods of standing, walking, or working in a cleanroom environment. 
• Ability to wear fully protective gowning for extended periods. 
• Must be able to lift and transport materials weighing up to 50 lbs. 
• Ability to consistently arrive at work for on time for shifts as assigned.

Physical Requirements

ADA Accommodation Notice
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
Physical Requirements
• Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
• Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE).
• Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
• Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures.