Senior Manufacturing Operator

Janssen Pharmaceuticals, Inc,  a division of the Johnson & Johnson Family of Companies, is recruiting for a  Senior 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.

GENERAL PURPOSE OF JOB

With minimal supervision, effectively performs duties related to the preparation and manufacture of active pharmaceutical ingredients, intermediates, and/or medical devices in accordance with standard operating procedures, as regulated by quality, environmental, and safety agencies (FDA, EPA, OSHA, DEA, etc.).

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Under minimal supervision operates all production processes within assigned area independently and effectively following detailed instructions.  Sets up, operates and cleans production equipment used to produce intermediate or finished products for Active Pharmaceutical Ingredients, Narcotic products or medical device raw material components, or other products as directed.  Completes all associated support activities in the production of these products.
• Possesses a broad working knowledge of manufacturing equipment and chemical processing principles.
• 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.
• Independently and effectively demonstrate operation of dryers, centrifuges, mills, reactors, water systems, DCS and PLC control systems and appropriately respond to alarms and interlocks.
• Reconfigure the plant for next process and perform comprehensive troubleshooting on production processes and various ancillary support processes; perform troubleshooting on equipment such as dryers and centrifuges as well as the ability to troubleshoot DCS/PLC controls and failure issues; resolve recurring/common problems involving tangible variables; and recognize abnormal operation of instrumentation.
• Demonstrate knowledge of potential failure modes for process related equipment and recommend remedial actions.
• Complete process sampling requirements following applicable schedules and techniques.
• Follow process and utility flow diagrams.
• Proactively updates/modifies existing procedure and operating instructions within assigned production area/processes.
• Transport materials of varying weight in accordance with established safety guidelines using material handling equipment and additional assistance as required.
• Demonstrate appropriate processes to other operators and explain what is occurring in support of training.
• Demonstrates basic knowledge and understanding of the operation of Site Utility Systems and their relationship to the production processes.
• Perform area safety inspections to identify safety hazards and report findings in accordance with company protocols.
• Demonstrates adherence to safety procedures by monitoring personal and peer behaviors, work environment and housekeeping.
• Participate in internal audits and support additional team activities as requested.
• Ensures DEA requirements are met with regard to sampling, documentation, and accountability of product. (Not applicable to ORC)
• Participate on site investigative teams and where applicable, in VSAs, PSSRs, PHAs, and behavioral safety assessments. Correct and/or mitigate findings from assessments.
• Provides overtime as needed

ADDITIONAL POSITION REQUIREMENTS

• Performs all duties with attention to quality, safety and environmental matters. Items include: 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.

• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA and DEA.  Complies with all company and site policies and procedures.

• Assume responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.

• Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

• Complete RCRA training within first six months of employment and annually thereafter.

• Complete all regulatory training as assigned (cGPM, ISO14001, OSHA, DEA, etc.).

• Complete Operator Training Program according to established guidelines.

• Be available for other projects or assignments as requested by management.

• 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 provide training to co-workers as needed and/or assigned; to improve upon current operations practices and systems; and to learn new skills, procedures and processes.