Hyde Engineering + Consulting provides engineering solutions and consulting services for the energy sector, particularly in the LNG and oil & gas industries. They specialize in process engineering, project management, and technology integration.
Not specified
INR 5.5 - 12.0 Lacs P.A.
Work from Office
Full Time
We are looking for a highly skilled CQV Engineer to support commissioning, qualification, and validation (CQV) activities for Injectable and Biologics Process Equipment, HVAC, Utility Systems, and pharmaceutical manufacturing processes. The ideal candidate should have experience in validation lifecycle, equipment qualification, risk assessments, and GMP compliance, with strong expertise in document review and execution. Key Responsibilities:Develop and execute CQV documentation such as CQMP, VMP, FRA, cGMP review sheets, and interdependencies.Prepare and execute qualification protocols (IQ, OQ, PQ), SOPs, process validation, and cleaning validation protocols.Perform risk assessments (SCA/SLIA, CLIA, SRA/QRA) and ensure compliance with cGMP regulations.Conduct commissioning and validation activities for Injectables, Biologics, API, Fill/Finish, and OSD pharmaceutical process equipment.Perform HVAC and Utility Systems commissioning and qualification.Work with process equipment including PFS, Cartridge, Vial, Isolators, Lyophilizer, Inspection Lines, and Packing Lines.Review, analyze, and interpret system performance data, preparing final report packages.Handle deviations, discrepancies, investigations, CAPA, and ensure ALCOA principles are followed.Ensure compliance with regulatory requirements, including GDP practices.Draft and review equipment operation SOPs and validation-related documentation.Utilize ValGenesis software for qualification activities (preferred).Work collaboratively within project teams and interact with regulatory bodies as needed.Required Qualifications & Skills:Bachelors/Masters degree in Chemical/Pharmaceutical Engineering or related field.4-10 years of experience in validation, quality systems, or engineering in a GMP environment.Strong expertise in Injectable and Biologics Process Equipment validation, HVAC & Utility Systems commissioning.Hands-on experience with equipment qualification and commissioning protocols.Experience with validation lifecycle approach, risk-based validation methodologies, and regulatory compliance (FDA, EU GMP, WHO).Knowledge of Documentum or Maximo (preferred).Strong analytical, documentation, and communication skills.Proficiency in Microsoft Office tools.Willingness to travel internationally with a valid passport (no legal restrictions).
Not specified
INR 1.0 - 5.5 Lacs P.A.
Work from Office
Full Time
Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors in the pharmaceutical and biopharmaceutical industries, resulting in the successful construction, commissioning and validation of facilities and equipment. As a member of the Hyde team, you will be responsible for providing state-of-the-art custom solutions to leaders in our industry. As we continue to grow our operations globally, we strive to hire the best talentmen and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits. You will find the following values reflected in our company:FamilyIntegrityRespectWisdomAdventure Position: Project Coordinator and Document ControllerLocation: HyderabadProject Coordinator will support our Technical team with project report drafting, tracking of projects, coordinating with client and internally for resources onboarding, demobilization, as well as support document management by maintaining project folders, formatting word files, excel files documents before client delivery, proofreading the documents, ensuring document management is followed as per the project, and administrative coordination and support marketing documents preparation and internal coordination for proposals. The assignments are broad in scope with the opportunity for the use of independent judgment to meet and exceed internal stakeholders and client expectations while working on technical projects.Responsibilities:Coordinate with cross-functional teams to collect and store required project information in compliance with internal quality standards and regulatory requirementsMaintain accurate and up-to-date project documentation, including reports, meeting minutes, schedules, deliverables and organize project files for electronic archiving.Ensure proper version control and document security in line with project management best practicesSupport project managers in tracking project timelines, milestones, and deliverables to ensure smooth execution.Assist in preparing project summaries, reports, and presentations as required.Communicate with internal and external stakeholders to gather updates and ensure smooth coordination.Proficient in MS Word, Excel, PowerPoint, MS Projects an added advantage and Outlook, to facilitate document tracking and workflow optimization.Assist in scheduling and organizing meetings, client interviews, follow-ups internally and externally when assigned specific tasks, and audits as required.Requirements:Bachelors degree, preferably in an Engineering or Science discipline.2 to 5 years’ experience within the pharmaceutical or other regulated industry Experience in document management, folder structuring, and regulatory compliance documentation.Strong organizational skills with a keen eye for detail and accuracy.Excellent written, verbal and communication skills.Excellent organizational skills.Strong project and client management skills.Excellent workflow and process analysis skills.Strong multitasking ability to manage variable workload across internal and external projects.Expertise in MS Word, Excel, Outlook, Project Management software.Willing to travel at client sites to perform the responsibilities as mentioned in this document.Possession of valid passport without any legal restrictions in terms of obtaining visa
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