- Responsible for design and operation of equipment to optimize chemical / biologic processes. Including troubleshooting, deviation investigations, EHS enhancements, ensuring compliance with regulatory and internal and external standards, driving digital transformation and implementing latest technology advancements.
- End-to-end project management from initiation through to GMP readiness release. Cover project chartering, designing, budgeting, scheduling, procurement, change plan authoring, site supervision, commissioning, supporting qualification, internal and external stakeholder management. Ensuring delivery against safety, quality and engineering compliance/standards driving project team to achieve project goals.
- Lead, analyze and evaluate new processes to determine requirements and feasibility introduction of these processes into the existing facility.
- Responsible for site CAPEX projects long term plan, management and reporting.
Manufacturing/ Operation Support:
- Lead troubleshooting, deviation investigation, engineering modifications, identification and completion of corrective and preventative actions.
- Lead modifications to equipment, processes and operations to improve safety, increase efficiency, production rates, efficiencies, yields, costs and enhance company goals.
- Provide operational support for the successful and uninterrupted operation of manufacturing systems used in manufacture of API and biologic products.
- Evaluate work processes and propose optimization and improvement which can involve digitization, artificial intelligence (AI) or automation solution.
Project Management:
- Act as the Subject Matter Expert (SME) for design, operation, control and optimization of chemical / biological processes
- Lead an deliver end-to-end management of complex projects or multiple projects concurrently and coordinate project interdependencies for OPEX projects
- Demonstrates strong financial expertise in managing project budgets and analyzing return on investment (ROI).
- Accountable for managing project costs to ensure delivery within the established budget.
- Develop long-range plans (LRP) for site capital projects, ensuring funds are available on time for project initiation, acting as the custodian of LRP funds, and overseeing timely capitalization of assets.
Requirements
- Degree in Engineering or relevant Technical Degree, coupled with at least 12 years of relevant work experience
- Knowledge of pharmaceutical regulatory requirements (GMP) is essential.
- Strong technical knowledge coupled with hands-on working experience in a pharmaceutical / biotechnology facility.
- Working experience and knowledge on equipment design, commissioning and qualification of start-ups and brownfield project experience is a plus.
- Demonstrates a results-oriented approach and is committed to meeting goals and metrics established.
- Comfortable to work in a fast paced environment and demonstrate full ownership of tasks assigned.
- Excellent attitude towards work and willingness to learn.
- Ability to work with teams including external contractors.
- Excellent team player and communication skills.
