Filling/Formulation Manufacturing Technician Team (Weekend Shift)

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

• 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.