Consultant - Data Validation

Job Description

Role Description: This role will form a core part of our Global Excellence Centre (GEC) Arcadis centralized and fully integrated project delivery group. Our GEC is made up of more than 3,000 talented individuals working in offices across India, Romania and Philippines, providing Capability, Capacity and a Competitive Advantage across a wide array of unique projects and services, in collaboration with our global businesses. Advanced Process Manufacturing within the GECs is comprised of cross-functional teams, that contribute to the design & development of innovative process engineering solutions in Pharmaceutical, Semi-Conductor & Process industries. Our ability to effectively manage projects, assess client needs, and provide technical guidance is crucial in delivering successful outcomes, using the most innovative way of doing computational design. Your role will include, but is not limited to: Preparation of plant equipment layouts, process flow diagrams, equipment sizing & P & IDs. Preparation of Specifications, for Process Equipment, Utility Equipment Warehouse Equipment etc. Mass & Energy balances to calculate Utility Load requirement. Knowledge of instrumentation Control requirement & Preparation of plant process control Philosophies. Provide required process input to Instrumentation team for instrument process data sheets. Input to project schedules and monitoring tasks to meet milestones during each phase. Develop documentation, diagrams, and specifications to meet project requirements and regulatory standards. Prepare scope of work documentation for use in project planning. Participate in project reviews to enable ongoing status tracking and reporting. Prepare & review project documents i.e. DQ, IQ, OQ & PQ Qualifications, FAT/SAT protocol & reports etc. Ensure adherence to industry standards and best practices in Process designing. Adhering to cGMP guidelines and work as per Arcadis SOP/Work instructions. Compliance to SHE & Sustainability Performs the tasks within the agreed-upon budget and schedule. Qualifications Mandatory: Bachelors degree in engineering (chemical, mechanical, industrial or similar). 8 years of experience as a process engineer in a design consultancy or GMP manufacturing environment. Knowledge of process analysis & process modelling. Working knowledge of process safety, risk assessment and compliance with regulatory standards. Good project management skills with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment. Nice to have: Masters degree in process engineering or a related field. Professional certification in process engineering or related areas. Experience with process automation and control systems. Knowledge of process simulation software and computer-aided design (CAD) tools. Solid understanding of quality management systems, such as ISO standards. Experience of sterile processing Knowledge of Hazardous Area Classification Experience of high potency pharmaceuticals Experience of both small molecule and large molecule process design