Responsibilities
* Manage and contribute throughout project, technology transfer, and commissioning/validation activities, providing process engineering expertise and leading or supporting cross-functional teams.
* Apply strong analytical, prioritization, and project execution skills, with experience in PAT, automation, SCADA/HMI, and cycle modelling
* Provide technical support to lyophilisation operations, engineering, and control systems to ensure efficient, compliant operations and achievement of project and production schedules.
* Ensure GMP compliance and data integrity of computerised systems, maintaining high system performance in line with site standards and regulatory expectations (FDA, EMA, ICH).
* Lead and support incident, deviation, and CAPA activities through effective investigation, root cause analysis, and timely implementation of corrective actions.
* Drive proactive problem solving, process optimisation, and continuous improvement initiatives using Lean Six Sigma, delivering measurable performance, cost, energy, and waste reduction benefits.
* Responsibilities also include training and developing staff, preparing and maintaining production SOPs and related documentation, promoting strong teamwork and a culture of safety awareness.
* The role ensures compliance with cGMP, ISO 14001, Health & Safety, and Environmental legislation,
* Supports cross-functional compliance efforts and operates equipment as required to support lyophilisation operations
Requirements
* Experience in freeze-drying/lyophilization projects or operations in pharma/biotech. (e.g., vial processing in Lyomax 30).
* Experience in a cGMP start up environment is preferred along with advanced technical experience including: expert knowledge relating to Aseptic vial Lyophilisation process, including CIP, SIP & FIT.
* Experienced with process control systems, process instrumentation, equipment qualification, and process validation.
* Possesses excellent organisational, interpersonal, verbal communication and written communication skills.
* Ability to work effectively using own initiative or as a member of a team as required.
* Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field