Manufacturing Specialist 2nd Shift Sterile Manufacturing

Job Listing No: 9740000

Manufacturing Specialist 2nd Shift Sterile Manufacturing

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Manufacturing Specialist 2nd Shift Sterile Manufacturing
The primary responsibilities of this role, Manufacturing Specialist 2nd Shift Sterile Manufacturing (Monday through Friday 2:00pm to 10:30pm), are to:
Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines;
Perform equipment setup and changeover activities. Take action to safely reduce equipment setup and changeover times;
Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications. Meet line Operational Asset Effectiveness requirements per the area targets. Ensure downtime is escalated properly;
Perform the daily setup and routine operation of the packaging line, including but not limited to: bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained;
Perform preventive maintenance tasks as needed and trained;
Troubleshoot Variable Frequency Drives and Servo Drive systems as trained;
Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions;
Palletize both finished and unfinished products, and operate motorized and non-motorized material handling equipment;
Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc.;
Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture (i.e. training team members, motivating and supporting team members, sharing knowledge to continuously Comply with all workplace standards and safety procedures, including improve the process, etc.);
Meet the production schedules outlined by line team and/or Supervision. Review and approve work output for team members by using validated methods;
Manage area cleaning requirements including facility, equipment, and Operational Excellence initiatives;
Area Specific Responsibilities:
Manage Material movement functionalities and dispensing of materials for planned batches;
Solid Dose Compounding
Manage Solids Compounding Operation that includes CIP (Clean In Place), EQ Setup, Raw Material Additions, and general process steps;
Manage Batch control system recipe operations;
Liquids Compounding
Manage Liquids Compounding Operations that include CIP (Clean In Place), SIP (Steam In Place), Equipment Setup, Raw Material Additions, and general process steps;
Manage Batch Control System Recipe Operations;
Sterile Filling
Perform the functions required for the Bio-Class I clean room;
Sterile filling and sterile filtration of all sterile drug solution products from bulk into final containers. This position will also include running the autoclave, terminal sterilizer, preparation of filling equipment and components, and maintaining area logbooks and housekeeping procedures. Includes monitoring, trouble shooting, and training for activities of filtration, and filling preparation which include basic understanding of MMI (Man Machine Interface) Systems, CIP (Clean In Place) Systems and SIP (Steam In Place) processes;
Participate in Sterile Media Fill qualifications for Sterile Filling and maintenance activities. This is a critical qualification for duties performed in the sterile core;
Disassemble, clean, reassemble, and prepare all sterile filling product contact equipment and supplies for sterilization;
Filling and Packaging
Perform line start-up to ensure the proper drug products, labels, and components are used in the filling/packaging process;
Manage filling and packaging operations with the ability to run all equipment in the area including filler, cartoner, labeler, bundler, etc. Must be proficient enough to train other operators.
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Required Qualifications:
High School diploma or equivalent required;
2 years of manufacturing experience;
Previous experience using automated inventory system is required (i.e., SAP, MES, etc.);
Previous experience using motorized & non-motorized material handling equipment required;
Demonstrated ability to successfully changeover/set up multiple pieces of packaging/manufacturing equipment and strong troubleshooting skills required;
Good written and verbal communication skills in English required;
Good PC Skills, including use of e-mail, attaching documents to e-mail required. Previous experience using electronic databases and on-line tools required (i.e., but not limited to, Lotus Notes database, Employee Self-Services on-line tools, etc);
Demonstrated ability to work safely in a production environment required;
Demonstrated ability to read/interpret/follow instructions in regard to workplace documentation, such as SOPs, Operator Manuals, Work Instructions, etc.;
Must be able to demonstrate a good mathematical aptitude in addition, subtraction, multiplication, division, & metric system;
Must be willing to work overtime as required, based on production demands;
(2nd Shift Monday through Friday 2:00pm to 10:30pm).
Preferred Qualifications:
Experience in a government regulated, Good Manufacturing Practices (GMP) or stan

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