Manufacturing Operations Specialist

Desired Skills: Operations,upstream,downstream,processing,change management,deviations,unit operations,Emerson,Delta V

PE Global is currently recruiting for a Manufacturing Operations Specialist for a leading multi-national Pharma client based in Co Meath.

This is a contract Shift position.

Role:

Reporting to the Process Operations Lead the Operations Specialist will support end-to end production operations for both Fed Batch and Continuous Manufacturing 

Primary activities/responsibilities:  

• 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.

Requirements:

• 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  

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***