The Manufacturing Technician I is an integral part of the team and will be responsible for manufacturing activities by following appropriate SOP(s) and supervisor direction, in accordance with current good manufacturing practices and policy and procedures. The Technician directly supports aseptic manufacturing for clinical and commercial products in a fast paced and dynamic environment. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. Responsibilities
• Maintains equipment log books and performs periodic review of documents.
• Responsible for maintaining the daily, weekly and monthly cleaning of the clean room facility
• Responsible for the cleaning and preparation of glassware and items for steam (Autoclave) and dry heat sterilization (Depyrogenation Oven)
• Operate laboratory instruments such as balances, pH meters, conductivity meters, mixers etc.
• Execute manufacturing activities following written manufacturing directions in accordance with current good manufacturing practices and AMRI policy and procedures
• Operates and troubleshoots manufacturing equipment and works closely with management and Quality as necessary
• Adheres to safety requirements at all times
• Will raise deviations in process to the attention of the shift supervisor
• Orders PPE and other manufacturing supplies as needed
• Understands and follows OSHA, HAZOP, and AMRI procedures and guidelines when handling or disposing of hazardous materials
• Performs waste container filling operations and applying identification markers and labels
• High-school education or equivalent required; associate’s degree or biotechnology certificate strongly preferred
• Experience in pharmaceutical manufacturing preferred; experience in the field in lieu of certificate program may be considered
• Ability to pass sterile gowning qualification required Preferred
• Previous cleanroom or cGMP experience is highly desirable
• Fill/finish or aseptic technique training strongly preferred Physical Demands While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. Work Environment While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate. Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
To apply for this job please visit pharmaboard.com.