Process Operations Specialist-Shift

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:

An amazing opportunity has arisen for a Process Operations Specialist to provide operational support for manufacturing operations of Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne Ireland.

Reports to: Drug Substance Process Operations Lead

Shift Pattern: 24/7 shift

Requirements

Responsibilities:

• Reporting to the Process Operations Lead the Operations Specialist will support end-to end production operations for both Fed Batch and Continuous Manufacturing
  
• Lead/Guide team members within the Production Operations team
  
• Coach and develop colleagues within the Production team
  
• Support team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution
  
• Lead facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.
  
• Responsible for monitoring operational performance follow-up on any significant adverse trends for the identification and implementation of operational optimization and robustness improvement projects.
  
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn improve and develop.
  
• A Change and QRA Champion within the organization and site to bring about new technologies digitization and identify opportunities to bring new ways of working.
  
• Lead complex process investigations on the production floor in support of deviation resolution.
  
• Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups
  
• Support team on 24/7 shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure issue resolution
  
• Conduct all work activities with a strict adherence to the safety and compliance culture on site
  
• Participate in safety process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate
  
• Write review and/or approve manufacturing documentation (SOPs Manufacturing Records & Logbooks)
  
• Ensure the effective use of material equipment and personnel in producing quality products.
  

Required Education Experience and Skills:

• Bachelor s degree in Biotechnology Chemistry Biology Pharmacy or Process engineering.
  
• 4 years experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
  
• Competent in analyzing complex situations and show practical problem-solving capabilities.
  
• Ability to work independently and within a cross-functional team.
  
• Understanding of multi column chromatography concepts
  
• Familiarity with contamination control and batch release requirements
  
• Experience leading presenting or supporting Regulatory Inspections and Site Internal Audits
  
• Problem Deviation and Change Management experience
  

Preferred Experience and Skills:

• Commissioning and Qualification experience
  
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
  
• Familiarity with Emerson DeltaV SIPAT and the use of Automation in a manufacturing Process.