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.
EDUCATION and/or EXPERIENCE
- High school diploma or general education degree (GED) required. Associates degree or equivalent preferred.
- At least 3 years work experience in similar chemical, pharmaceutical, or industry that complies with cGMP is required.
- Must be able to read, write, and understand Basic English.
- Read and interpret documents such as safety rules, operating and maintenance instructions, government regulations and procedure manuals.
- Write routine reports, operating procedures and correspondence.
- Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Compute rate, ratio, and percent and draw and interpret bar graphs.
- Calculate figures and amounts such as proportions, percentages, area, and volume.
- Perform conversions from metric units to English units and vice versa.
- Follow and interpret a variety of instructions furnished in written, oral, diagram, or schedule form with a minimal level of supervision.
- Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
OTHER SKILLS ABILITIES OR QUALIFICATIONS
- Operating skills of manufacturing equipment, tools, and hand/fork trucks.
- Demonstrated PC navigation skills such as the ability to enter data into programs/software applications and use software applications for mail, word processing, spreadsheets and other job specific needs. Able to run various reports and perform analysis of data, graphs, and trends using computer programs.
- Knowledge of DCS and SAP systems.
- Perform a variety of tasks, paying attention to detail, without a loss of production.
- Work well with others in a team environment, influencing people in opinions and attitudes.
- Possesses a sense of duty; is willing to go the extra mile to get the job done.
- Takes initiative as problems and/or opportunities arise; is action oriented; does all that should be done, not only as directed.
- Demonstrate knowledge/use of Process Excellence principles.
- While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms.
- The employee is frequently required to talk or hear and taste or smell.
- Must have the ability to work from ladders or platforms up to 30 feet in the air and the ability to lift, push or pull up to 40 pounds.
- Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.
- While working in this job the employee is frequently exposed to outside weather conditions including extreme heat and cold.
- Must be able to qualify for respiratory protective equipment use.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.