Manufacturing Operator

Janssen Pharmaceuticals, Inc, a division of the Johnson & Johnson Family of Companies, is recruiting for a  Manufacturing Operator  located in  Athens, Georgia .

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Manufacturing Operator is responsible for performing duties related to the preparation and manufacture of active pharmaceutical ingredients, intermediates, and/or medical devices. These responsibilities include using equipment for the assembly and processing tasks to produce finished products according to established specifications and in accordance with standard operating procedures, as regulated by quality, environmental, and safety agencies (FDA, EPA, OSHA, DEA, etc.).

• Possesses a basic understanding of a limited number of chemical production processes within area of assignment and a working knowledge of manufacturing equipment and chemical processing principles
• Sets up, operates and cleans production equipment used to produce intermediate or finished products for Active Pharmaceutical Ingredients, Narcotic products, medical device raw material components, or other products as directed; Completes all associated support activities in the production of these products.
• Follows and accurately completes batch records/logs, SAP transactions and other documentation associated with all production processes to ensure efficient operations and compliance with cGMP and standard operating procedures.
• Demonstrates effective operation of dryers, centrifuges, mills, reactors, water systems, DCS and PLC control systems and appropriately responds to alarms and interlocks.
• Transports materials of varying weight in accordance with established safety guidelines using material handling equipment and additional assistance as required
• Performs area safety inspections to identify safety hazards and report findings in accordance with company protocols.
• Performs all duties with attention to quality, safety and environmental matters including: wearing appropriate personal protective equipment, recognizing, reporting, and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, and properly labeling and storing chemicals.
• Completes process sampling requirements following applicable schedules and techniques.
• Demonstrates adherence to safety procedures by monitoring personal and peer behaviors, work environment and housekeeping.
• Ensures DEA requirements are met about sampling, documentation, and accountability of product, if applicable.
• Compiles records and reports on quality inspection results.
• Performs basic troubleshooting on equipment such as dryers and centrifuges as well as DCS/PLC controls and failure issues and recognizes abnormal operation of instrumentation.
• Participates on site investigative teams and where applicable, in VSAs, PSSRs, PHAs, and behavioral safety assessments; Corrects and/or mitigates findings from assessments.
• Live Our Credo and the Janssen Purpose by putting the need of Our Credo stakeholders first, pursuing the highest standards of compliance, quality and ethics.
• Connect inclusively within the department, with other departments, and within the company to address customer needs.
• Shape the future through innovation by inspiring new ideas, trying new things, and demonstrating resilience and agility to adapt to change.
• Grow by developing self and others to reach goals by engaging in open and honest conversations, managing energy, and taking ownership for outcomes.

Additional position requirements:

• Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.
• Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties.
• Partners with Supervisor and Quality Department in making recommendations to modify existing procedures, instructions and batch logs within the assigned production processes as well as developing new procedures, instructions, and batch logs.
• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Maintain compliance with all company and site policies and procedures and the intent of our Credo.
• Completes RCRA training within first six months of employment and annually thereafter
• Completes all regulatory training as assigned (cGMP, ISO14001, OSHA, DEA, etc.)
• Completes Operator Training Program according to established guidelines.
• Accountable to ensure the Area is prepared for internal and external audits. Participates in audits as necessary. Drives documentation and housekeeping practices to assure a continuous state of inspection readiness.
• Continuously looks for ways to simplify or improve products, services, systems, and processes to achieve business goals, e.g., improve yield, cycle time, quality, and productivity.
• Makes a positive contribution through demonstration of ability to seek out assistance from co-workers as needed, to suggest ways to improve upon current operations practices and systems; and to learn new skills, procedures and processes.
• Be available for overtime work on a scheduled or emergency basis.