Industry Pharma/Biotech/Clinical Research
Work Experience 1-3 years
City Carlow
State/Province Carlow
Country Ireland
Job Description
As part of the IPT team, perform various production and operations related tasks to aid in the manufacture and reliable supply of product.
Ensure objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
This is a 24/7 shift role (Onsite).
Requirements
Role Functions
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 will include, but is not limited to, 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.
Manage equipment flow, including tracking soiled and clean hold times, proper labelling 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 preventive 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; 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.
Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in performance of day-to-day activities and all applicable job functions.
Work collaboratively to drive a safe and compliant culture.
May be required to perform other duties as assigned.
Experience, Knowledge & Skills
Technical
Sterile filling processes and equipment.
Knowledge of regulatory/code requirements to Irish, European and International Codes.
Standards and Practices.
Proficiency in Microsoft Office and job related computer applications.
Business
Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment and with external customers.
Understand specific responsibilities of all departments as they relate to one's own department, understanding the business processes one's department supports.
Self-motivated.
Flexible approach.
Effective time management and multi-tasking skills.
Excellent attention to detail.
Goal/results oriented.
Leadership
Focus on Customers and Patients.
Act with Candor and Courage.
Make Rapid, Disciplined Decisions.
Drive Results.
Build Talent.
Demonstrate Ethics and Integrity.
Qualifications & Education
Leaving Certificate or equivalent required.
Apprenticeship, Certificate or Diploma preferred, ideally in a related discipline.
Typical Minimum Experience for this Grade/Level: Prior related work experience, ideally in manufacturing, preferably GMP setting.
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