Manufacturing Specialist Sterile Fill - 1st Shift (M-F 6:00am-2:30pm)

Argenta (New Zealand); Shawnee (KS); Sur place; USD 42 000 - 63 000; Plein temps

Résumé du poste

Argenta, based in Shawnee, KS, seeks a Manufacturing Specialist to join a high‑precision line team. You will perform sterile filling operations, setup/changeover of packaging equipment, and ensure GMP compliance while maintaining documentation and line efficiency.

Responsibilities include operating the packaging line, troubleshooting drives, and participating in sterile processing. Candidates need a high school diploma, 2 years of manufacturing experience, and strong communication skills in

Qualifications

• High School Diploma or GED required.
• 2 years of manufacturing experience.
• Experience using automated inventory systems.
• Experience with motorized and non-motorized material handling equipment.
• Ability to changeover and set up multiple packaging/manufacturing equipment.
• Good written and verbal communication in English.
• Experience in GMP or SOP environments.

Responsabilités

• Comply with workplace standards and safety procedures (cGMPs/OSHA/SOPs).
• Set up and changeover packaging lines to minimize downtime.
• Optimize equipment parameters to meet production specs and targets.
• Operate packaging line including bottle in-feed, filler, capper, labeler, and related systems.
• Perform preventive maintenance and troubleshoot drive systems as trained.
• Maintain production documentation (SAP/MES/EBRs) for material movements and yields.
• Support training to develop high performance competencies and teamwork.
• Meet production schedules and review team output using validated methods.
• Maintain area cleaning and participate in GMP-related responsibilities.
• Work in Bio-Class I clean room; sterile filling/filtration and autoclave operations.

Connaissances

Manufacturing experience

Inventory systems

Material handling

Equipment changeover

English communication

GMP/SOP experience

Overtime readiness

Formation

High School Diploma

GED

Outils

SAP

MES

EBRs

Description du poste

At Argenta, we’re more than a company — we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.

Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market.

We’re in a unique position. We are the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health.

Our uniqueness means:

• We are ambitious, growing and building a ‘one team’ culture, guided by our values.
  • We are team players;
  • We are doers;
  • We are customer-centric;
  • We are innovators.

We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better.

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.

TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply.

Argenta is currently looking to fill the role Manufacturing Specialist at our Shawnee, KS location.

Job Summary

Perform operations in a line team environment to provide high quality pharmaceutical products on time and in the right quantities to customers.

Key Responsibilities

• Comply with all workplace standards and safety procedures, including 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. Act 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 area targets. Escalate downtime 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), et al.
• Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a collaborative culture (i.e., training team members, motivating, and supporting team members, sharing knowledge to continuously improve the process).
• 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:
• 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.
• Other duties as assigned.

Qualifications

• High School Diploma or GED.
• 2 years manufacturing experience.
• Previous experience using automated inventory systems.
• Previous experience using motorized & non-motorized material handling equipment.
• Demonstrated ability to successfully changeover/set up multiple pieces of packaging/manufacturing equipment and strong troubleshooting skills.
• Good written and verbal communication skills in English.
• Good PC Skills, including use of e-mail, attaching documents to e-mail. Previous experience using electronic databases and on-line tools.
• Demonstrate ability to work safely in a production environment.
• A ability to read/interpret/follow instructions regarding workplace documentation.
• Possess a good mathematical aptitude in addition, subtraction, multiplication, division, & metric system.
• Experience in a government regulated, Good Manufacturing Practices (GMP) or standard operating procedures (SOP) environment.
• Must be willing to work overtime as required, based on production demands.
• This is an on-site position.