Manufacturing Lead - Sterile Filling - 3rd shift (Sunday - Thursday 10:00 PM - 6:30 AM)

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 Lead - Sterile Filling - 3rd shift at our Shawnee, KS location

List Responsibilities

1.  Ensure safe work environment by following all safety procedures, workplace standards, company guidelines, and ergonomic rules. These include proper use of personal protective equipment (PPE), Standard Operating Procedures (SOP), Current Good Manufacturing Practices (cGMP), Occupational Safety and Health Administration requirements (OSHA), and lockout tagout.

2.  Dispense components, operate, clean, set-up, changeover and maintain equipment and rooms to manufacture products. Clean and maintain process equipment which may include, but not limited to tanks, fillers, pumps, blenders, mills, presses, and coating pans.

3. Assist with technical troubleshooting and preventive maintenance tasks as needed and trained. Take action to safely reduce equipment setup and changeover times. Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications.

4. Ensure product quality by performing in-process checks, complying with Current Good Manufacturing Practices, being alert for unacceptable quality of incoming/outgoing materials, initiating quality improvements, and participating on quality improvement projects.

5. Communicate quality and other noncompliance issues to supervision in a timely manner.

6. Accurately record on the appropriate documents the process/manufacturing steps, production results, equipment in-process checks, samplings, cleanings, ingredients used, and any other required Current Good Manufacturing Practices information. Maintain daily production sheets and time sheets for team.  Review and approve work output for team members by using validated methods. Perform work to complete, maintain, and update production documentation (both electronic and paper). Perform material movements, material take-outs and yield determinations by utilizing systems as required such as Systems Applications Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRS).

7. Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications.  Meet line Operational Asset Effectiveness requirements per area targets.    Perform preventive maintenance tasks as needed and trained.

8. Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions.

9. Perform the functions required for the Bio-Class I clean room

10. 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.

11. Participate in Sterile Media Fill qualifications for Sterile Filling and maintenance activities. This is a critical qualification for duties performed in the sterile core.

12. Disassemble, clean, reassemble, and prepare all sterile filling product contact equipment and supplies for sterilization.

List Requirements

1. 5 years manufacturing experience.

2. 5 years in a government regulated Good Manufacturing Practices (GMP) or Standard Operating Procedures (SOP) environment required.

3. Previous experience using automated inventory system is required (i.e., SAP, MES, etc.).

4. Previous experience using motorized & non-motorized material handling equipment required.

5. SAP or other Enterprise Resource Planning (ERP) experience highly desired.

6. Good written and verbal communication skills in English required.

7. Good PC Skills, including use of e-mail, attaching documents to e-mail required.

8. Previous experience using electronic databases and on-line tools required.

9. Demonstrated ability to work safely in a production environment required.

10. Demonstrated ability to read/interpret/follow instructions regarding workplace documentation, such as SOP’s, Operator Manuals, Work Instructions, etc.

11. Must be able to demonstrate a good mathematical aptitude in addition, subtraction, multiplication, division, & metric system.

12. Must be willing to work overtime as required, based on production demands.

13. Effective communication and customer service skills.

Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued.  At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through strong culture, great benefits, and opportunity for growth.

Argenta is an equal opportunity employer

To find out more about Argenta, click here: www.argentaglobal.com