Overview
As part of the IPT team, perform various production and operations related tasks to aid in the manufacture and reliable supply of product. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
Key Accountabilities
With a RFT mindset operate and/or monitor production activities and support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs. Equipment includes parts washers, autoclaves, portable tank CIP/SIP/storage panels, Vial Washer, Depyro Tunnel, Debagger and filling machines.
Clean room cleaning, housekeeping and materials management in all production areas while focusing on continuous process improvement using Lean Principles.
Fully Certified and Proficient on all Equipment, Processes and Tasks in the room.
Knowing factory priorities/schedule through RTMS. Acting proactively without direction.
Manage equipment flow, including tracking soiled and clean hold times, proper labeling and inventory management of clean and sterile equipment using Kanbans and automated MES system to set QC status and expiry of sterile equipment.
Maintain process equipment, completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.
Participate effectively in writing/revising/rolling out accurate operational procedures, training materials for various IPT systems; ensure all work is carried out in line with same.
Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Perform root cause analysis, using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
Highlights roadblocks or issues from a people, safety, quality or delivery perspective in a timely manner.
Able to perform routine day to day problem solving for assigned area independently or when working as part of a team.
Engage in Tier 1 process at both start and end of shift. Asking relevant questions and providing detailed information.
Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Take ownership of your own safety & adhere to all safety procedures and programs.
Obtain and Maintain all required safety certifications independently.
Work collaboratively to drive a safe and compliant culture.
May be required to perform other duties as assigned.
Job Requirements
This role is a site-based role.
This a 24/7 shift role.
Clear understanding and demonstrated cleanroom, sterile behaviors & ALCOA Principles.
Eager to learn and progress and take feedback.
Flexible and engaged in Shift Versatility.
Involved in training fellow work mates.
Engaged in Enablon.
Manual Handling, Material transfer & Pallet truck Certifications.
PSA/Airlock Management. Knowing what good looks like.
Engaged in TAT and a clear understanding of zones and expectations.
Understanding of logging Down Time and using SEEQ.
Validations, Tech Eng & Maintenance support where required.
Basic Batch review/release & PO Closures.
1 Improvement Project or OPPs completed Per Year.
Educational and Experience Requirements
Typical Minimum Education: Leaving Certificate or equivalent required; Apprenticeship, Certificate or Diploma preferred; ideally in a related discipline.
#J-18808-Ljbffr