Janssen Pharmaceuticals Inc. is recruiting for a Senior Manufacturing Process Engineer in Athens. GA .
The Senior Process Engineer provides support for the Active Pharmaceutical Ingredient (API), 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 cycle time, yield, and quality to support process and operational efficiency. Support introduction and validation of new and existing products. Provides input and experience for new equipment design, installation, and qualification.
- Provides day-to-day support of assigned processes. Creates and maintains documentation such as batch production records, operational procedures, criticality analysis, and key and controlled parameter documents.
- Conduct or participate in troubleshooting efforts by analysis and correction of both process and equipment problems 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.
- Represent Operations in engineering projects and 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.
- Lead and execute the 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, 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 Expert / Owner or System (equipment) Owner.
- Mentors, and assists in the development of peers and Process Engineers.
- Produces high quality and accurate work in a timely manner to meet the production schedule.
- Lead and coordinate multiple projects priorities and works 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 responsibilities.
- Participate in plant safety programs such as PHAs/LOPAs of new and existing processes to maintain and/or improve operational safety.
- Serve on various committees and teams to enhance operations at the Janssen Pharmaceuticals, Inc. plant site, Georgia campus and API-SM cluster 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. Maintain compliance 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 personal work and of work performed as a team.
- Successfully complete regulatory and job training requirements.
- Maintaining proper housekeeping at all times.
- Be available for overtime work on a scheduled or emergency basis. Travel may be necessary.
- Other projects or assignments as requested by management.
- May serve as a production supervisor as required.
- May supervise co-op students, interns, and entry level Process Engineers.
B.S. in Chemical Engineering, Mechanical Engineering, or Chemistry; generally, requires four to six years of related experience (2 – 4 years experience with M.S. in relevant discipline). Experience in a chemical manufacturing environment is required.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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 .
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.