Janssen Pharmaceuticals, LLC is currently hiring for a Staff Process Engineer 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 Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

Job description:

The Staff Process Engineer has responsibility for the API manufacturing processes and intermediates or the medical device raw material or medical device component manufacturing processes. Provides technical support for processes including performing analysis to measure process performance and implementing improvements in process cycle time, yield, and quality to improve operations efficiency. Support introduction and validation of new and existing products. Lead projects involving new equipment design, installation and qualification.

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.
• Conduct and/or participate in problem solving efforts by analysis and improvement of processes and equipment issues to maintain or improve existing site operations.
• 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.
• Prepare reports to advise leadership 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.
• Support the introduction of new processes by coordinating and performing the preparation activities for process start-ups and supply technical coverage.
• Assist in process and equipment design to support new products and the legacy product portfolio.
• Implement cost reduction and efficiency improvement projects using Process or Design Excellence techniques. Applies appropriate risk management tools such as FMEA, HAZOP, LOPA and business risk evaluations.
• Conduct training for operations and maintenance personnel.
• Maintain knowledge of cGMPs, process safety practices and environmental standards.

Additional position requirements:

• Serves in the role of a Synthesis Owner, Synthesis Owner Leader, Product Owner or System (equipment) Owner.
• Mentors, and assists in the development of peers and Process Engineers.
• Required to produce high quality and accurate work in a timely manner to meet the production schedule.
• Lead and coordinate multiple projects. Prioritize and work effectively across the organization in completing them 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 complete their work.
• Participate in plant safety programs such as PHA’s for processes to maintain and/or improve operational safety.
• 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 laws and guidelines including FDA, EPA, OSHA and DEA. Follow all company and site policies and procedures and the intent of our Credo.
• Assume responsibility for the safety, environmental, quality, and business effects of personal work and of work performed as a team.
• Maintains proper housekeeping at all times.
• Be available for overtime work on a scheduled or emergency basis. Travel may be required.
• Other projects or assignments as requested by management.

Supervisory responsibilities

• May supervise co-ops, interns and junior level Process Engineers.

Qualifications

Qualifications

• A Bachelor’s degree in chemical engineering or related field is required. A Master’s degree is preferred.
• 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.
• Project management, organizing, planning and coordination skills is required.
• Strong mind-set and knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) is required.
• Use and application of process excellence, statistics, lean production concepts preferred.
• Strong business insight and understanding of financials is preferred.
• Ability to lead and encourage multi-functional teams (local and global) is required.
• Strong communication skills are required.
• Knowledge of end-to-end supply chain is preferred.
• Ability to influence peers and people at higher levels within the organization is preferred.
• Affinity with data analytics tools is preferred.
• Experience in Medical Device business is preferred.
• Ability to seek innovation and change to ensure competitiveness is preferred.

Physical demands

• This position will be located in Athens, GA and may require up to 10% domestic and international travel.
• While performing the duties, the employee is regularly required to sit, use hands to finger or feel and reach with hands and arms.
• Ability to qualify for respiratory protective equipment use.
• Capable of moving around the plant to perform on-site investigations.

Other:

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.

The job demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties are not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

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