Production Operator

About PSC Biotech

Who are we?

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.

Overview:

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  requirements
to ensure compliance, safety and reliable supply to our customers.
This is the Shift role 24/7 (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, 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 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 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  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:

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 ones
  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.