Production Operator

3 months ago

Carlow, Ireland PSC Biotech Ltd Full time
Job Description
About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Role Description:

  • As part of the IPT team, perform various production and operations related tasks as part of an empowered team to aid in the manufacture and reliable supply of product. Ensure that objectives are effectively achieved, consistent with client’s requirements to ensure compliance, safety and reliable supply to our customers.


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, yet 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 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.
  • Required to comply with client 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.
  • Work collaboratively to drive a safe and compliant culture.
  • May be required to perform other duties as assigned.

 

Experience, Knowledge & Skills:

Core Competencies:

Technical:

  • Sterile filling processes and equipment
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Proficiency in Microsoft Office and job related computer applications required

 

Business:

  • Effective communication and interpersonal skills to interface effectively with all levels of
  • colleagues in a team environment, and with external customers
  • Understand the specific responsibilities of all departments as they relate to ones
  • own department, understanding the business processes one’s department supports
  • Customer service
  • Self-motivated
  • Flexible approach
  • Effective time management and multi-tasking skills
  • Excellent attention to detail
  • Trouble shooting skills
  • Goal/results orientated
  • Training skills

 

Leadership:

  • Focus on Customers and Patients
  • Collaborate
  • Act with Candor and Courage
  • Make Rapid, Disciplined Decisions
  • Drive Results
  • Build Talent
  • Demonstrate Ethics and Integrity

 

Qualifications & Education:
Typical Minimum Education:

  • Leaving Certificate or equivalent required
  • Apprenticeship, Certificate or Diploma preferred, ideally in a related discipline

Typical Minimum Experience for this Grade/Level:

  • Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting. 

#LI-XA1

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, yet 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 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. Required to comply with client 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. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Experience, Knowledge & Skills: Core Competencies: Technical: Sterile filling processes and equipment Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Proficiency in Microsoft Office and job related computer applications required Business: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers Understand the specific responsibilities of all departments as they relate to ones own department, understanding the business processes one’s department supports Customer service Self-motivated Flexible approach Effective time management and multi-tasking skills Excellent attention to detail Trouble shooting skills Goal/results orientated Training skills Leadership: Focus on Customers and Patients Collaborate Act with Candor and Courage Make Rapid, Disciplined Decisions Drive Results Build Talent Demonstrate Ethics and Integrity Qualifications & Education: Typical Minimum Education: Leaving Certificate or equivalent required Apprenticeship, Certificate or Diploma preferred, ideally in a related discipline Typical Minimum Experience for this Grade/Level: Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting. #LI-XA1

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