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Associate Manufacturing Process Engineer
Company: Johnson & Johnson
Location: Athens, GA
Employment Type: Full Time
Date Posted: 05/03/2021
Expire Date: 07/14/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Computers, Software, Customer Service and Call Center, Engineering, Finance/Economics, Healthcare, Practitioner and Technician, Information Technology, Installation, Maintenance, and Repair, Legal, Manufacturing and Production, Quality Control, Research & Development, Medical, Environmental, Energy / Utilities
Job Description
Associate Manufacturing Process Engineer

Janssen Pharmaceuticals, Inc. part of the Johnson & Johnson Family of Companies, is recruiting for an Associate Manufacturing 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.

 

As an Associate Manufacturing Process Engineer, you will provide technical support for Active Pharmaceutical Ingredient (API), medical device raw material, or medical device component manufacturing processes under the supervision and mentorship of senior-level engineers and operations management. These responsibilities include measurement and analysis of process performance, implement improvements in process cycle time, yield, and quality to improve operational efficiency, support introduction and validation of new and existing products, and provide feedback for 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, operational procedures, criticality analysis, and key and controlled parameter documents.
  • Conduct or participate in improvement 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 Technical Operations in local and value stream engineering projects and coordinates 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 small scale 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.
  • Evaluates and advises in new and existing process and equipment design.
  • Execute cost reduction and efficiency improvement projects using Lean, Process, or Design Excellence techniques.
  • Utilizes appropriate risk management tools such as FMEA, HAZOP, LOPA and business risk evaluations.
  • Maintain knowledge of cGMPs, process safety practices and environmental standards.
  • Grow and develop others by conducting training for operations and maintenance personnel.
  • 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.
  • Connect inclusively within the department, with other departments, and within the company to address customer needs.
  • Shape the future through innovation by inspiring new ideas, trying new things, and demonstrating resilience and agility to adapt to change.
  • Grow by developing self and others to reach goals by engaging in open and honest conversations, managing energy, and taking ownership for outcomes.

Additional position requirements:

  • Serves in the role of a Synthesis Expert / Owner or System (equipment) Owner.
  • Produce high quality and accurate work in a timely manner to meet the production schedule.
  • Lead and coordinate multiple project 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.
  • Serve on various committees and teams to enhance operations at Athens Janssen Pharmaceuticals, Inc. 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.
  • Responsible for handling-controlled substance in compliance with applicable State and local law and J&J requirement.
  • 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.
  • Be available for work outside the business hours.
  • Other projects or assignments as requested by management.

Supervisory responsibilities

  • May serve as a production supervisor as the need arises.
  • May supervise co-op students, intern.
  • May mentor Associate Process Engineers.

Qualifications

Education:

  • Bachelor’s Degree required.
  • Chemical Engineering, Mechanical Engineering, Biomedical Engineering/Bioengineering or Chemistry preferred.

 

Experience and Skills:

Required:

  • A minimum of 2 years of work experience in a chemical, pharmaceutical, medical device or similarly regulated manufacturing industry.
  • Demonstrated ability to write effectively to communicate work prepared, rationalize conclusions and recommendations, and compliantly document for regulatory bodies.
  • Ability to read, analyze, and interpret complex scientific and technical journals, financial reports, and legal documents.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Work effectively with others in a diverse and inclusive matrix environment.
  • Ability to effectively present information to site management, public groups, and/or boards of directors.
  • Ability to define problems, collect relevant data and information, establish facts, and draw valid conclusions.

 

Preferred:

  • Experience with TrackWise, SAP, Minitab, and Visio.
  • Experience with process control systems (e.g., Emerson DeltaV) and data historian software (e.g., OSi PI).
  • Solid understanding of Word, Power Point, and Excel.

 

Other:

  • Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
  • Regularly required to talk and hear, stand, walk, sit, use hands to finger, handle or feel, and reach with hands and arms.
  • Required to move around the manufacturing plant to perform on-site investigations.
  • Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.
  • Must qualify for respiratory protective equipment use.

 

This position is based in Athens, GA will require up to 10% domestic/international travel.

 

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.


Primary Location
United States-Georgia-Athens-1440 Olympic Drive
Organization
Janssen Pharmaceuticals, Inc. (6062)
Job Function
Engineering
Requisition ID
2105925467W
Contact Information
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