Lead Manufacturing Operator
Job Description
Janssen Pharmaceuticals, LLC is recruiting for a Lead Manufacturing Operator in located in Athens, GA!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies.
The Lead Manufacturing Operator performs duties related to the preparation and manufacture of intermediate or finished products for Active Pharmaceutical Ingredients, Narcotic products or medical device raw material components, or other products in accordance with standard operating procedures, as supervised by quality, environmental, and safety agencies (FDA, EPA, OSHA, DEA, etc.). In addition to conducting the duties of a Manufacturing Operator, assumes 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.
Key Responsibilities
• Coordinates and prioritizes operator activities on their shift on behalf of their supervisor to efficiently lead production schedule. Monitors progress of operators throughout shift as needed.
• Independently operates all production processes within assigned area and optimally follows detailed instructions.
• Possesses an instructing level of knowledge of manufacturing equipment and chemical processing principles. Able to train operators in multiple areas in the operation of various production processes.
• 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 optimally demonstrate operation of dryers, centrifuges, mills, reactors, water systems, DCS and PLC control systems and appropriately respond to alarms and interlocks.
• 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.
• Perform 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. 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 requirement.
• 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.
• Responsible for handling controlled substance in compliance with applicable State and local law and J&J requirements.
• Participate on site investigative teams and where applicable, in VSAs, PSSRs, PHAs, and behavioral safety assessments. Correct and/or mitigate findings from assessments.
• Contribute to EHS investigations as a departmental resource for resolution and CAPA identification.
• Partner with change owners to develop and implement COCs. Initiates Emergency COCs as needed in accordance with existing procedures to continue production in a safe manner while protecting product quality.
• Actively partners with appropriate personnel to initiate, assess, and resolve deviations and CAPAs.
• 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.
Education
• High school diploma required.
• Vocational, Certificate, Technical or Associates preferred.
Experience And Skills
Required:
• 6+ years of related manufacturing work experience.
• Able to read, write, and understand Basic English and read and interpret documents such as safety rules, operating and maintenance instructions, government regulations and procedure manuals.
• Operating skills of manufacturing equipment, tools, and hand/fork trucks.
• Ability to follow and interpret instructions furnished in written, oral, diagram, or schedule format.
• Ability to communicate and effectively work as part of a team.
• Perform tasks, paying attention to detail, without a loss of production.
• Must be willing and able to work overtime as needed.
• Ability to work rotating 12-hour shifts required which may include days and/or nights, in support of continuous operations.
• Be able qualify for respiratory protective equipment use.
Preferred
• 18+ months’ work experience in chemical, pharmaceutical, or industry that aligns with cGMP environment.
• Able to write plant/operational status description, quality and/or safety assessments, and operating procedures.
• Ability to issue permits for safe work, class 2 hot work, breaking into process, lockout/tagout plan, and confined space entry.
• Ability to tackle practical problems and deal with concrete variables in situations where only limited standardization exists.
• Able to lead others in the use of DCS/PLC, SAP, and other computer systems.
Other
• Be able to meet the physical demands of this job which include: standing, walking, climbing, bending, stooping, reaching with hands and arms, handle or feel; frequently required to talk, hear; must be able to work from ladders or platforms up to 30 feet in the air and the ability to lift, push or pull up to 40 lbs.
• 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.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location
NA-US-Georgia-Athens
Organization
Janssen Pharmaceuticals, Inc. (6062)
Job Function
Production
Job Qualifications
Qualifications
Hospitals and Health Care
Management and Manufacturing
Full-time