5 Performance Qualification Jobs

As a Senior Engineer in Gas Distribution Systems (GDS) and Fluid Systems, your role involves leading proposal and detailed engineering activities while enhancing the capability of the engineering team. You will play a crucial part in delivering top-notch technical solutions, engaging in technical discussions for business development, and establishing engineering standards within the organization. **Key Responsibilities:** - Lead the design and engineering of modular gas and liquid systems, encompassing gas generation units like N, O, H, blending, metering, blanketing, and pressure control skids. - Support the Business Development team by addressing technical queries (TQs) and offering optimized engineering solutions. - Take ownership of the development of PFDs, P&IDs, routing, layout, instrumentation, and component selection, such as valves, regulators, sensors, transmitters, and heat exchangers. - Prepare cost estimates, BOQs, and preliminary engineering documents for customer approval. - Supervise the preparation and finalization of PFDs, P&IDs, GA drawings, layouts, and routing plans. - Drive engineering excellence in mass transfer, energy transfer, and fluid control strategies. - Specify and size process equipment while ensuring compliance with relevant standards such as ASME, API, and TEMA. - Collaborate with automation, instrumentation, and electrical teams for integrated solutions. **Engineering Standards & Capability Building:** - Establish a solution library and component database for quicker turnaround times and enhanced sales support. - Recommend and develop a range of modular, standardized systems that are both repeatable and scalable. - Create engineering checklists and quality gates for project deliverables. - Mentor and train junior engineers in process design, documentation, and industry best practices. **Solution Mapping Across Market Segments:** - Analyze various industry segments including Oil & Gas, Petrochemicals, Specialty Chemicals, Fertilizers, Pharmaceuticals, Energy, Hydrogen, etc. - Identify specific process applications where the Company can provide standardized, modular solutions. - Recommend and develop a portfolio of standard systems for consistent marketing and sales across diverse projects and clients. - Guide the creation of a solution library aligned with industry needs and business expansion goals. These responsibilities will involve collaboration with external consultants for project-specific technical requirements, engaging external Subject Matter Experts (SMEs) for advanced technical capabilities, and overseeing Operational Qualification (OQ) and Performance Qualification (PQ) for manufactured systems.,

You will be responsible for preparing and reviewing validation documents such as Area Qualification for new facilities, Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Control System Qualification, commissioning, validation & re-qualification, and Revision Qualification for equipment/utilities/facilities. You will generate reports that summarize results, specifications, and acceptance criteria. Your role will also involve authoring documents in ValGenesis. In addition, you will track SOPs due for review, circulate them for comments, update comments, initiate change control, initiate ERA workflow, and follow up for execution, approval, and closure. You will prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements. Reviewing Calibration reports and updating them on a daily basis will also be part of your responsibilities. Furthermore, you will be required to prepare, track Purchase orders, update data sheets, arrange quotes for new equipment as needed, and update the required status and database for engineering activities in an Excel sheet. Initiating QAMS documents in Caliber will also be one of your tasks. Qualifications: - B.E./B. Tech Experience: - 7 to 8 Years,

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Following a new opportunity, we are currently looking for a Junior Consultant: Qualification & Validation (CQV) to join our team in an onsite project at Rupnagar (Chandigarh) Location. The ideal candidate should have 2+ years of experience in a similar role and be able to review and update P&ID, prepare Qualification Documents like Validation Plan, Design Qualification, User requirement specification, Installation Qualification, Operational Qualification, Performance Qualification, System impact assessment, Functional Risk Assessment, Qualification summary report, Standard Operating Procedure (SOP), Change Control, and drafting DCS-PLC Process write up. The candidate should also be willing to travel and relocate as per project requirements anywhere in India and global locations after the project completion. An immediate joiner is required (20 Days). Location: Rupnagar (Ropar) - Punjab, near Chandigarh. As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers you the opportunity to work on international projects, enhance your skills, and engage with colleagues from around the world. If you are seeking a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.,

You will be working as a Validation Manager at EVOL ORTHO TECH located in Bengaluru, India. The company is involved in the manufacturing of knee orthopaedic implants for the Indian Market. Established as a greenfield project in 2025, EVOL ORTHO TECH is a Joint-Venture between a French and Mauritius Based Company. As a Validation Manager, you will report to the Quality & Regulatory Affairs General Manager and oversee a team of 3 members after ramp-up. The ideal candidate will hold a BE (MECHANICAL) degree or equivalent qualification. Your primary responsibilities will include managing process monitoring, material analysis tests, preparing qualification and validation files, handling process change requests, subcontractor change requests, and design change requests. You will also be responsible for audits, releasing production batches, document control, product release, managing the qualification process, projects, analysis of standards, and creating new tools. In terms of managerial responsibilities, you will act as the technical point of contact for the department, organize the team's work, ensure availability of resources, report malfunctions, ensure compliance with company rules and the quality system, provide guidance, training, participate in recruitment, monitor integration/training, communicate information, escalate problems, conduct interviews, and motivate the team. The ideal candidate should have knowledge of quality control, experience in design qualification, installation qualification, operational qualification, performance qualification, writing skills, proficiency in IT tools, fluency in English, project management experience, familiarity with CDSCO regulations, and skills such as rigor, organization, analytical ability, communication, good writing skills, management, leadership, conviction, and team spirit.,

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report