7.0 - 11.0 years

0 Lacs

karnataka

On-site

PM Group, a leading International engineering, architecture, project, and construction management firm, is seeking a Senior Piping Design Engineer to join the Piping Department in Bangalore. With a global network of offices and a dedicated team of over 3,700 professionals, we specialize in delivering complex capital projects in various sectors such as life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy, and environmental. As a Senior Piping Design Engineer at PM Group, your responsibilities will include coordinating with other offices to understand project scope, deliverables, timelines, and man-hours. You will be tasked with producing and reviewing intricate piping plans, layouts, isometric sketches, and electronic 3D models in alignment with project requirements, codes, specifications, and procedures. Additionally, you will be involved in 3D Piping Design, isometric generation from Process P&ID's, stress analysis, clash checking for pipe clashes, and coordinating design with other disciplines and vendors. Qualified candidates should possess a degree in Mechanical Engineering, a minimum of 7 years of piping design experience, and at least 3 years of experience using Intergraph's S3D & CADWorx suite of products. Experience in biopharmaceutical or API design is preferred, along with a background in working with clients from Europe and the USA. Strong interpersonal and communication skills are essential, and a willingness to travel to Europe for 1 to 3 months for selected projects is expected. At PM Group, we are an employee-owned company that values inclusivity, commitment, and drive. Our 2025 business strategy is centered around Corporate Responsibility and Sustainability, with a focus on fostering a culture of Inclusion and Diversity. We are dedicated to creating a workplace where mutual respect and belonging are paramount, by embracing a diverse workforce rich in talent and ideas. By recognizing and honoring the unique contributions of all individuals, we aim to ensure our continued growth and success into the future.,

Posted 2 days ago

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Team Lead Regulatory Affairs DDReg Pharma

5.0 - 9.0 years

0 Lacs

haryana

On-site

The primary responsibility of this role is to manage Regulatory Affairs in compliance with relevant regulations and guidelines for the organization. As a Regulatory Affairs Manager at DDReg, you will be involved in reviewing clinical, biopharmaceutical, non-clinical, and labelling documentation. Your duties will include preparing and reviewing non-CMC sections, Variations, site transfers, and conducting post-approval gap analysis. Additionally, you will support the regulatory function through document management, electronic submission compilation, and other group management activities as needed. Collaboration with various departments such as Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research and Development will be necessary to ensure regulatory compliance and operational excellence. Your responsibilities will involve providing high-quality reviews of CTD sections for regulatory filings to various regulatory authorities such as EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia, and other markets globally. You will actively contribute to developing and implementing regulatory strategies, processes, and timelines for global approval. Conducting Gap Analysis of Non-CMC sections, authoring and compiling CTDs sections, preparing labelling documentation, managing labelling changes, and ensuring compliance with regulatory guidelines will be key aspects of your role. Furthermore, you will be required to demonstrate expertise in regulatory matters, collaborate with internal and external stakeholders, and provide technical consultation and advice on strategy and industry best practices. To excel in this role, you should possess a Bachelor's or Master's degree in Pharma and have at least 5+ years of relevant experience in the pharmaceutical/CRO industry. Strong project management skills, excellent interpersonal and communication skills, and in-depth knowledge of global regulatory guidelines are essential for success. Proficiency in Microsoft Word, PowerPoint, and Excel, along with the ability to work effectively in a team-oriented environment, are also crucial requirements. The ideal candidate should be adaptable, capable of working under pressure, and able to deliver high-quality results within tight timelines. This position is based in Gurgaon, Haryana, India. Occasionally, you may be required to work across different time zones to fulfill job requirements.,

Posted 3 days ago

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Deputy Manager To Manager(Project Mgmt Biologics)Bangalore Search Advisers Services Guj

3.0 - 8.0 years

7 - 14 Lacs

Bengaluru

Work from Office

Please share updated resume at anita.searchrx@gmail.com Role & responsibilities This role demands a very entrepreneurial and self-driven individual with technical knowledge of bioprocesses, ability to collaborate with cross-functional teams, develop techno-commercial proposal, project management and excellent communication skills with multicultural and multi-geographical stakeholders Preferred candidate profile Understanding the technical and scope of a project Preparing techno- commercial proposals for customers Providing technical support to BD and Sales team Project management of all projects from kick off to deliveries across R&D, Pilot and manufacturing Review commercial and legal contracts with the CFO team

Posted 1 month ago

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