Lead Manufacturing Operator
Johnson & Johnson Innovative Medicine
Summary
The Lead Manufacturing Operator performs duties related to the preparation and manufacture of intermediate or finished products for Active Pharmaceutical Ingredients (API), Narcotic products, or medical device raw material components, according to Standard Operating Procedures (SOPs) and as regulated by quality, environmental, and safety agencies (FDA, EPA, OSHA, DEA, etc.). In addition to conducting the duties of a Manufacturing Operator, the Lead will also assume responsibility for coordinating and prioritizing activities of operators on their shift on behalf of their supervisor and performing various support activities for assigned shift/plant.
Job description
Key Responsibilities
- Support shift's supervisor and coordinate and prioritize operator activities to effectively manage production schedule, and monitor operators' progress throughout shift as needed.
- Independently operate all production processes within assigned area and optimally follows detailed instructions.
- Follow and accurately complete batch records/logs, SAP transactions, and other documentation associated with all production processes to ensure efficient operations and compliance with cGMP and SOPs.
- 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 troubleshoot DCS/PLC controls and failure issues.
- Complete process sampling requirements following applicable schedules and techniques, and follow process and utility flow diagrams.
- Transport materials of varying weight according to established safety guidelines, using material handling equipment and additional assistance as required.
- Perform all duties with attention to quality, safety, and environmental matters including wearing appropriate PPE, recognizing and responding to hazards, maintaining housekeeping, and properly labeling and storing chemicals.
- Demonstrate knowledge and use of process safety management (PSM) and participate in a PSM review or audit.
- Handle controlled substance in compliance with applicable State and local laws and J&J requirements.
- Continuously seek ways to simplify or improve products, services, systems, and processes to achieve business goals.
- Provide training to co-workers as needed and/or assigned; support training and knowledge transfer of manufacturing equipment and chemical processing to operators across multiple production areas.
Qualifications
Minimum of a High School or equivalent diploma is required; Vocational, Technical/Trade, or Associates certificate/degree preferred.
Requires proficiency in English to effectively interpret documents such as safety rules, operating and maintenance instructions, government regulations, and procedure manuals. Must be willing and able to meet the physical demands of this job including standing, walking, climbing, bending, stooping, reaching, working from ladders or platforms up to 30 feet, lifting/pushing/pulling up to 40 lbs., and observing through close vision, distance vision, color vision, depth perception, and adjusting focus. Must be able to qualify for respiratory protective equipment use. Requires ability to work onsite during rotating 12-hour shifts including days and nights and alternating weekends, and work overtime as needed. May require up to 10% domestic & international travel.
Requirements
- Minimum of a High School or equivalent diploma
- Minimum 6 years of relevant work experience
- Minimum 6 months' work experience in similar chemical, pharmaceutical, or industry that adheres to cGMP environment
- Ability to operate manufacturing equipment, tools, and hand/fork trucks
- Knowledge of manufacturing equipment and chemical processing principles
- Demonstrated knowledge of potential failure modes for process related equipment and ability to recommend remedial actions
- Basic Math skills including addition, subtraction, multiplication, division, fractions, decimals, rate, ratio, percent, proportions, percentages, area, volume, and metric/English conversions
- Demonstrated basic computer navigation skills and ability to run various reports
- Ability to solve practical problems and deal with a variety of concrete variables
- Ability to communicate and effectively work as part of a team environment
- Take initiative as problems or opportunities arise and perform various tasks with attention to detail
- Proficiency in English (read, write, understand)
- Must be willing and able to meet physical demands including lifting up to 40 lbs. and working from ladders up to 30 feet
- Must be able to qualify for respiratory protective equipment use
- Requires ability to work onsite during rotating 12-hour shifts including days, nights, and alternating weekends
- May require up to 10% domestic & international travel
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.