Position Details

The TSA Process Engineer applies process engineering expertise to bridge science and technical operations.. This key individual contributor supports process and equipment design, start-up and operational readiness, and technology transfer. Ensures safe, robust processes that meet quality and business requirements, from scaling existing processes to implementing and scaling new ones. Manufacturing scope includes drug substance and drug product operations (e.g., fermentation, viral egg propagation, protein purification, oral solid dose, and lyophilisation).
This is a self-managed individual-contributor role requiring strong academic and professional experience. Coaches and mentors junior team members, leads delegated initiatives, and provides input to operations support and continuous improvement engineers.

EDUCATION
Honors Degrees in Engineering or Science with 10years experience or Masters degree in a technical discipline (e.g. chemical engineering, biochemistry, biotechnology, biopharmaceuticals) with 7years relevant experience. 

EXPERIENCE
7-10 years’ experience in the biotechnology and/or pharmaceutical industry, with Operational experience of NPI and product support.  
Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals.
Experience in process and equipment qualifications including authoring, review and execution of studies and reports is a must.
Handson experience with protein purification techniques a distinct advantage.
Project Management Certification e.g. PMI is a benefit.
Chartered Engineering Status is a benefit. 

RESPONSIBILITIES
Serve as a process engineering subject matter expert for vaccine manufacturing and be a recognized technical leader.
Provide on-the-floor technical support to Production Team Leaders for process/equipment optimisation, troubleshooting, and scale-up during tech transfer.
Support commissioning and validation activities.
Ensure process transfers to production are technically and organisationally feasible, meeting robustness, timeline, cost, safety, regulatory, and documentation requirements.
Partner with manufacturing teams to support batches, introduce new technologies/processes, and resolve technical issues.
Author technical documentation for tech transfer, process monitoring, and improvement; support equipment/new technology implementation and act as production-monitoring lead in project meetings.
Define material, consumables, waste, and outputs for production batches (process mass balance).
Prepare feasibility studies and operating budgets for future product transfers (product fit assessments).
Investigate complex production deviations during new product introductions and routine manufacturing.
Support EHS hazard and operability (HAZOP) studies for new processes and equipment.
Collaborate internally and externally on technical initiatives.

CORE COMPETENCIES
Analytical thinker who identifies solutions in complex problems and data.
Stays current with literature and emerging technologies.
Strong knowledge of GMP, ICH, and compendial regulations and guidance.
Proven ability to lead root-cause analysis and effective investigations.
Problem-solving, risk management, and decision-making skills.
Attention to detail with significant data review experience.
Technical writing skills (e.g., deviations, validation reports).

Travel may be required up to 10%