Role We are seeking a Process or Mechanical Engineer with experience in NPI and Tech Transfer, capable of leading teams to deliver projects on time, on budget, and meeting technical, quality, and regulatory standards.
Pharmaceutical process knowledge, equipment specification, and validation experience are required.
Responsibilities: Supervise junior engineers as required.
Develop process estimates, including equipment costs.
Oversee project change control, ensuring c GMP compliance.
Support process development, technical transfer, troubleshooting, and optimization.
Comply with safety policies, regulations, and current Good Manufacturing Practice.
Support validation activities (FAT, IQ, OQ) and review validation documentation.
Maintain accurate reporting of process changes impacting project scope, schedule, or budget.
Manage equipment specification, process design, commissioning, and as-built documentation.
Participate in project and continuous improvement meetings/workshops, Hazop reviews, and SOP updates.
Provide technical support for new and existing equipment, including troubleshooting and process investigations.
Coordinate cross-functional design, production, and support teams to deliver projects on time and within budget.
Lead process design for new products, equipment, and processes ensuring safety, quality, regulatory, and operational compliance.
Qualification and Experience Knowledge of ATEX and Hazardous Area Zoning.
Experience with secondary pharmaceutical manufacturing processes (e.g., fill lines).
Strong planning, organizational, and project execution skills.
B.
Eng in Chemical, Process, or Mechanical Engineering, or relevant science/engineering discipline.
Minimum 8+ years experience in process engineering within Pharma, Biotech, or Chemical industries.