Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Manufacturing Process Engineer to be based in Athens, GA.
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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
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 Associate Manufacturing Process Engineer will be responsible for the following:
- Providing technical support to the API manufacturing processes.
- Performing analysis to measure process performance; implementing improvements in process cycle time, yield, and quality to maximize operations efficiency; supporting introduction and validation of new and existing products; and providing expertise to new equipment design, installation and qualification. These tasks are usually performed under the supervision and guidance of senior-level engineers or operations management.
- Learn to provide day-to-day process engineering support of assigned processes.
- Maintain, update and author necessary production, safety and regulatory documentation such as operating instructions, batch production records, criticality analysis, piping and instrumentation diagrams, key and controlled parameter documents, deviations, and corrective action plans.
- Participate in troubleshooting efforts by analysis and correction of both process and equipment problems to maintain or improve existing site operations.
- Implement, under supervision, process surveillance programs on issues such as process control, yields, cycle times, quality, and change over. Prepare written interpretations of plant operating data and implements corrective action.
- Coordinate small engineering projects.
- Prepare reports (campaign, monthly, or ad hoc) to keep management informed of work in progress with expected completion dates.
- Conduct or participate in development projects including laboratory, pilot plant or plant scale investigations to provide improved procedures, equipment or processes for existing products.
- Write and execute process and cleaning validation of new and existing products.
- Support the introduction of new processes by coordinating and executing the preparation activities for process start-ups and supply technical coverage.
- Assist in new and existing process and equipment design.
- Execute cost reduction and productivity improvement projects using Process or Design Excellence techniques. Utilizes appropriate risk management tools such as FMEA, HAZOP, and business risk evaluations.
- Conduct training for operations and maintenance personnel.
- Maintain knowledge of cGMPs, process safety practices and environmental standards.
- Assist in the role of a Synthesis Expert or System (equipment) Owner.
- Must be able to produce high quality and accurate work in a timely manner to meet the production schedule.
- Manage and coordinate multiple project priorities and work effectively across the organization in completing projects on time and in budget.
- Involvement with PLC’s, DCS/BPCS will vary by plant – these systems are tools used by the Process Engineer to accomplish the job deliverables.
- Participate in plant safety programs such as PHA’s of new and existing processes to maintain and/or improve operations safety.
- Serve on various committees and teams to enhance operations at the plant site as requested by supervision.
- Assist in the preparation for, and detailing with various regulatory agency audits (i.e., FDA inspections, Corporate QA audits, in-house QA audits). Assists in keeping regulatory documentation current.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Comply with all company and site policies and procedures and the intent of our Credo.
- Assume responsibility for the safety, environmental, quality, and business effects of work performed.
- Successfully complete regulatory and job training requirements.
- Maintaining proper housekeeping at all times.
- Be available for overtime work on a scheduled or emergency basis. Occasional travel may be necessary, sometime for extended periods of time (weeks), and may include international locations.
- Other projects or assignments as requested by management.
- B.S. in Chemical Engineering, Mechanical Engineering, Biomedical Engineering/Bioengineering, or Chemistry is required.
- Prior work experience in a chemical, pharmaceutical, or similar manufacturing industry that complies with cGMP is highly preferred.
- Experience or familiarity with batch process control systems is preferred
- The ability to analyze and troubleshoot computer and equipment systems is required
- Ability to communicate and effectively work as part of a team is required
- Experience with Root Cause problem solving tools and writing investigations is preferred
- Familiarity with Lean or Six Sigma Principles is preferred
- This positon is based in Athens, GA and requires up to 10% travel both domestic and international
Janssen Pharmaceuticals, Inc (6062)Job Function