Operations Lead Biotech Associate

About the role

MSD is looking for an Operations Lead Biotech Associate for its site in Dunboyne, Ireland. This is a site-based, 24/7 shift role (4 on 4 off) open to candidates with both upstream and downstream experience. The role supports end-to-end production operations within a specific manufacturing IPT and acts as a Unit Op Lead.

Key responsibilities

• Take ownership of activities within the assigned suite and unit operation, acting as a delegate for the shift lead when unavailable
• Deliver shift standard work through a team-based approach to batch progression, following work instructions and SOPs
• Run handover boards, give updates to shift leads and act as escalation point for troubleshooting, problem solving and continuous improvement projects
• Ensure activities are done right first time, with accurate Electronic Batch Record reviews and real-time batch record, SAP Comet and elogs checks by the end of the shift
• Author, review and edit procedures and technical documents under cGMP, coach teams on RFT documentation and maintain GMP and safety standards
• Take part in safety walkdowns, audits, risk assessments, CAPA oversight and cross-functional manufacturing teams
• Lead approved projects and continuous improvement initiatives, using real-time data analytics to drive value stream improvements

Required profile

• Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy or Process Engineering
• 5+ years of experience in the biotech industry, including bulk manufacturing of pharmaceutical or biological components
• Familiarity with contamination control and batch release requirements
• Ability to work independently and within a cross-functional team

Required skills

• Proficiency with Delta V, Pas X and automation in manufacturing
• Experience with single-use technologies
• Troubleshooting and practical problem solving