Janssen Cilag LLC, part of the Johnson & Johnson Family of Companies, is recruiting a Parenteral Manufacturing Operator for the facility located in Gurabo, Puerto Rico.

At 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. We pursue the most promising science, wherever it may be found. Janssen Pharmaceuticals, Inc. provides medicines for a variety of health issues across multiple therapeutic areas, including cardiovascular, metabolic, mental health, and pain management. Visit www.JanssenPharmaceuticalsInc.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.

Master parenteral manufacturing operations in at least four or more of the following processes: Formulation, Equipment and Component Preparation, Area and Equipment Sanitization, Aseptic Filling, Lyophilization, Sealing, Inspection, and Packaging. Execute and detail in accordance with cGMP policies and practices, EHS procedures, manufacturing records, and inventory control systems (both automated/electronic and manual, such as SAP). Perform medium complexity diagnostics on mechanical or electronic equipment failures in operational areas under your responsibility. Train new personnel or peers as part of the cross-training program. Must be the Subject Matter Expert (SME) and mentor in the processes under your responsibility. May coordinate activities and personnel within the functional area of your responsibility.

Key Responsibilities:

• Implement and master production activities and operate machinery in four (4) or more functional areas of parenteral manufacturing and packaging.

• Perform basic troubleshooting and/or assist maintenance technicians in troubleshooting equipment in your functional area.

• Document, review, and verify equipment calibrations (scales, control equipment, instrumentation, etc.) prior to use in accordance with current procedures.

• Ensure that all components to be used are approved and aligned with specifications.

• Weigh raw materials and excipients and verify that their appearance, expiration date, and lot number conform to work orders and specifications before starting the weighing and/or manufacturing process.

• Implement manufacturing and packaging activities for all business units, following manufacturing and packaging instructions; detail these activities in the corresponding manual or electronic manufacturing records (e-PES, SAP).

• Perform and detail the final inventory of used materials and rejected materials in the corresponding system of e-PES, SAP.

• Assist in the review and update of work instructions and job safety analyses (JSA).

• Perform transactions in the inventory control system for movement, inventory changes, and verification of availability of materials to be used in the process (SAP, e-PES).

• Ensure that the parameters of the process rooms, such as temperature, humidity, pressure differential, etc., meet specifications before, during, and after the process.

• Document activities performed: cleaning, assembly, disassembly, etc., in the corresponding records or documentation systems in accordance with Good Manufacturing Practices and current documentation rules.

Qualifications:

Required

• Associate's Degree or equivalent experience in Science or related field

• A minimum of four to six (4 to 6) years of experience in a regulated industry

• Ability to read, write, and understand both Spanish and English

• Good knowledge of Good Manufacturing Practices, Documentation Rules, Occupational and Environmental Safety

• Knowledge in the use of computerized inventory control and document management systems

• Basic skills in mathematical operations

• Must be available to work 1st, 2nd, 3rd, and 4th shifts (12 hours). Additionally, must be available to work overtime, weekends, and irregular hours.

Preferred:

• Bachelor's Degree or equivalent experience in Administration, Science, Engineering, or related field

• Training and certification in Lean/Six-Sigma tools

• Basic knowledge of manufacturing processes, from raw materials to final product

• Basic troubleshooting skills

• Skills in using computerized programs: SAP and e-PES

• A minimum of two (2) years of experience in the parenteral pharmaceutical industry

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.