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

Requirements

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 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.
  
• 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
  
• Highlights roadblocks or issues from a people, safety,
  quality or delivery perspective in a timely manner Highlights roadblocks or
  issues from a people, safety, quality or delivery perspective in a timely
  manner
  
• 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