Lead Manufacturing Bioprocess Associate – Operations

About the role

The Lead Manufacturing Bioprocess Associate provides operational support for shop‑floor activities of the Late Stage and Launch Pipeline at MSD's new state‑of‑the‑art single‑use biotechnology facility in Dunboyne. This is a site‑based, 24/7 shift position that requires strong technical expertise and teamwork.

Key responsibilities

• Support end‑to‑end production for both batch and continuous manufacturing, operating equipment according to electronic batch records, sampling plans and SOPs.
• Work within a dedicated process team, offering flexibility, problem‑solving and continuous learning.
• Provide weekend or on‑call coverage as required to sustain manufacturing output.
• Author and maintain electronic batch records, sampling plans, work instructions and SOPs.
• Lead and guide team members in one or more unit operations.
• Collaborate with Facility Management to maintain GMP status of equipment through routine monitoring, calibration, maintenance and certification.

Required profile

• Bachelor’s degree in biotechnology, chemistry, biology, pharmacy or process engineering.
• Minimum 5 years experience in biotech bulk manufacturing of pharmaceutical or biological components.
• Proven troubleshooting ability and practical problem‑solving skills.
• Ability to work independently and within cross‑functional teams.
• Understanding of multi‑column chromatography and bioreactor operation.
• Familiarity with contamination control, batch release requirements, Emerson DeltaV, PAS‑X and automation in manufacturing.
• Experience with single‑use techniques, commissioning, qualification and GMP equipment management.
• Background in problem, deviation and change management.

Required skills

• Bioreactors
• Multi‑column chromatography
• Emerson DeltaV
• PAS‑X
• Single‑use technology
• Commissioning & qualification
• GMP equipment monitoring, calibration & certification
• Problem, deviation & change management
• Continuous improvement
• Troubleshooting
• Upstream and downstream operations
• Automation
• Electronic batch records