Within Janssen Pharmaceuticals Supply Chain MSAT (Manufacturing Science and Technology) Small Molecule Drug Substance, we are seeking a highly qualified and motivated individual to join the team as a Staff Process Engineer at our Johnson & Johnson campus in Athens, Georgia!
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 Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.
In this role, you will be responsible for the API manufacturing processes and intermediates. You will provide technical support for processes including performing analysis to measure process performance, process modeling, and implementing improvements in cycle time, yield, and quality to increase operational efficiency.
You will also help to shape the introduction and the validation of new and existing products.
Do you have strong skills in data analysis and problem-solving? Are you a systems thinker with a passion for process design, improvement, and implementation? Do you consider yourself to be a successful mentor to assist in the development of peers and Process Engineers?
If so, you may be the candidate we are looking for!
Key Responsibilities:
• Provides day-to-day support of assigned processes.
• Creates and maintains documentation such as batch production records, operating procedures, criticality analyses, and key and controlled parameter documents.
• Lead and/or participate in univariate and multivariate analyses of production data to develop process improvements, resolve manufacturing issues, drive cost reduction projects, and enhance existing site production steps.
• Responsible for 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.
• Support the introduction of new processes by coordinating and driving the preparation activities for process start-ups and supply technical coverage.
• Lead and implement the process and cleaning validation activities for new and legacy products.
• Conduct or participate in development projects including laboratory, pilot plant or plant scale investigations to provide improved procedures and processes for our portfolio.
• Represent MSAT in engineering projects and coordinate small engineering projects.
• Uses appropriate risk management tools such as FMEA, HAZOP, LOPA and business risk evaluations.
• Maintain knowledge of cGMPs, process safety practices and environmental standards.
QUALIFICATIONS
Qualifications
Education:
• A Bachelor’s degree in chemical engineering or related field is required. A Master’s degree is preferred.
Qualifications:
• A minimum of 6 years of experience in an industrialized manufacturing environment involving pharmaceuticals/chemicals is required (minimum 4 years with Master's degree in relevant field).
• Experience in chemical manufacturing processes, technologies and products is required.
• Strong mind-set and knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) is required.
• Ability to lead and encourage multi-functional teams (local and global) is required.
• Experience in Small Molecule API business is preferred.
• Affinity with data analytics tools including univariate and multivariate analyses and modeling is preferred.
• Project management, organizing, planning and coordination skills is preferred.
• Use and application of process excellence, statistics, lean production concepts preferred.
• Strong business insight and understanding of financials is preferred.
• Change leadership and seeking innovative, value creating solutions is preferred.
• Strong communication skills and the ability to influence peers and people at higher levels within the organization is preferred.
Other:
• May require up to 10% domestic and international travel.
• Read, analyze, and interpret complex scientific and technical journals, financial reports, and legal documents.
• Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Effectively present information to site management, public groups, and/or boards of directors.
Mathematical skills
• Apply advanced mathematical and statistical concepts.
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Define problems, collect data or information, establish facts, and develop conclusions.
Other skills abilities or qualifications
• Works effectively with others and with minimal guidance.
• Lead and coordinate multiple project priorities.
• Computer knowledge, primarily Microsoft Word and Excel, Minitab, Visio and other modelling and data analysis tools.
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 .
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Employment Type: OTHER