8 Ispe Jobs

As a C&Q Engineer at Jacobs, you will be responsible for project delivery, design management & project management, for positioning and winning projects involving a range of services. You will collaborate with commercial, project management, engineering, and design technical leaders to create opportunities for Jacobs to plan, develop, deliver, and operate a range of projects. **Role And Responsibilities:** - Knowledge of Risk-based Integrated C&Q approach - Provide input into all aspects of C&Q from design through to commissioning and qualification completion - Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements - Prepare C&Q protocols a...

Should be able to act as the global SME for plant utilities and energy management in the pharmaceutical industry (sterile and non-sterile) Should be able to plan, design and prepare the deliverables independently required in different project phases like feasibility studies, conceptual design, Front-End Engineering Design (FEED) and detail design related to plant utility systems. Should have strong knowledge about greenfield and brownfield projects from inception till execution including validation /commissioning including strong troubleshooting and problem-solving abilities. Should have excellent knowledge on key topics like steam boilers, condensate recovery systems, compressed air, nitrog...

Job Title: Automation + Pharma Validation Trainer Location: Remote Job type: Part-time Job Summary: We are seeking an experienced trainer to deliver hands-on training in Automation systems and Pharma Validation . The role involves designing training modules , mentoring candidates , and preparing them for industry certifications , regulatory audits , and interviews . This position is ideal for professionals with a strong background in pharma automation , CSV , and regulatory compliance who are passionate about teaching and career development . Key Responsibilities: Conduct training on Automation systems ( SCADA, PLC, DCS ) and Pharma Validation ( CSV, IQ/OQ/PQ, 21 CFR Part 11, GAMP5 ) Build m...

As a Process Engineer, you will be responsible for supporting basic and detailed engineering design in process industries. Your role will involve preparing heat/mass balances, equipment sizing/selection, PFDs, P&IDs, BOMs, and datasheets. Additionally, you will coordinate with vendors, control costs, and provide on-site support. You will engage in technical discussions with stakeholders, clients, and consultants, offering technical input throughout the project lifecycle. Key Responsibilities: - Perform process calculations including line sizing, pump hydraulics, heat exchangers, and selection of control valves/PRVs/PSVs. - Develop and review PFDs, P&IDs, datasheets, and technical specificati...

As a Technical Director Piping in Plant Design Engineering consulting for Life Sciences, Pharma, and Biotech facilities, your role involves deep expertise in piping design, layout, and engineering standards for complex, regulated facilities. You will be a key player in defining and implementing piping design standards, best practices, and guiding the team in preparing specifications for piping materials, valves, fittings, and specialty items. Additionally, you will provide expert oversight for pipe stress analysis, flexibility studies, and support design, collaborating with various disciplines to ensure seamless integration in plant design. Key Responsibilities: - Serve as the Subject Matter...

Key Responsibilities : Design and develop sophisticated and attractive automation solutions for pharmaceutical equipment (PLC, SCADA, HMI), leveraging state of the art tools and technologies. This includes: Lead the evaluation and selection of automation tools and frameworks, ensuring scalability, reliability, and ease of use. Lead the planning from development to validation phase. Write documentation required by the project (specifications, design report, user instruction, ) in compliance with internal procedures & external requirements (ISPE GAMP, GMP, Eudralex, FDA & EHS requirements). Maintain our product up to date, support our customers/services team for automation issues. Find the bes...

- Handling vendor approval requests – filling forms, Questionnaires, sharing FAQ, documents etc. - Handling regulatory requests / queries from customers. - Maintenance of regulatory documentation in electronic format and saving key communication. Required Candidate profile - 2+ years of experience in Pharma Regulatory Affairs. - B.Pharm / M.Pharm - Good Communication skills, Time Management and IT skills

As a dedicated Qualification Professional, you will be responsible for overseeing the execution of Pre-Factory Acceptance Tests (Pre-FAT), Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT) in accordance with established test protocols. Your primary role will involve engaging directly with customers to ensure adherence to test specifications and securing necessary documentation and approvals during FAT at our facilities and SAT at customer locations. You will be expected to conduct thorough testing and troubleshooting of systems, including SCADA, to ensure optimal performance. Additionally, you will monitor and address Non-Conformance Reports (NCRs) arising during Pre-FAT, FAT, ...