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Role Overview
We are seeking a Design Engineer to support the design for process and process engineering for Facility set up of pharmaceutical manufacturing processes. The role involves working closely with cross-functional teams to develop efficient, compliant, and scalable process engineering design for facilities for drug substance and/or drug product manufacturing.
Key Responsibilities
- Facility Design and Engineering for Process & related services
- Design and develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and material and energy balances for pharmaceutical processes
- Review of Client process requirement and design of the process requirements for a manufacturing facility
- Preparation of URS for Process Equipment in compliance to the regulatory requirements for Drug Substance and Drug Product Manufacturing facilities
- Conduct process simulations and feasibility studies to optimize yield, efficiency, and cost
- Collaborate with R&D, manufacturing, quality, and engineering teams to ensure robust process design
- Ensure compliance with regulatory requirements including cGMP, US FDA, EMA, and other global standards
- Participate in risk assessments (HAZOP, FMEA, CCS) and implement mitigation strategies
- Support commissioning, qualification (IQ/OQ/PQ), and startup of manufacturing equipment and facilities
- Troubleshoot process design issues and drive continuous improvement initiatives
- Prepare and review technical documentation, including DQ, IQ, OQ, FAT, SAT, FDS, PQ and other documentation related to facility qualification requirement.
- Work with external vendors and engineering partners for equipment design and selection
Required Qualifications
- Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Mechanical Engineering, or related field
- 3–6 years of experience in process engineering & facility design within the pharmaceutical, biotech, or life sciences industry
- Strong understanding of unit operations such as fermentation, fill-finish, aseptic processes, mixing, filtration, drying, granulation, crystallization, etc.
- Experience with process simulation tools (e.g., Aspen Plus, ChemCAD) is preferred
- Knowledge of cGMP, regulatory guidelines, and validation requirements
- Familiarity with cleanroom design and aseptic processing is a plus
Key Skills & Competencies
- Strong analytical and problem-solving skills
- Ability to interpret and develop engineering drawings and technical documentation
- Effective communication and stakeholder management
- Detail-oriented with a focus on quality and compliance
- Ability to work in cross-functional and fast-paced environments
Preferred Experience
- Experience in API or formulation process engineering design of manufacturing facilities
- Exposure to continuous manufacturing or digital/automation tools
- Prior involvement in design of greenfield or brownfield projects
Why Join us
- Opportunity to work on cutting-edge pharmaceutical projects
- Exposure to global regulatory standards and advanced technologies
- Collaborative and innovation-driven work environment
- Strong career growth and learning opportunities and competitive pay
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