We have an exciting opportunity for the position of Pharma Equipment Engineering – Specialist.

     Biopharma Equipment Engineering

1.      Person should possess strong understanding of biopharmaceutical manufacturing processes including upstream, downstream, formulation, filling, and support operations.

2.      Responsible for client interactions to understand requirements, develop conceptual options, prepare technical presentations, and obtain client approval during project development stages.

3.      Responsible for ensuring that Company and Group technical policies are followed while considering client-specific and regulatory requirements.

4.      Should possess strong knowledge of facility planning and layout development for biotechnology, vaccine, monoclonal antibody (mAbs), recombinant protein, cell and gene therapy facilities.

5.      Ensure all work complies with Client Standards and Engineering Practices as described in the Project Coordination Procedure.

6.      Should possess expert knowledge of contamination control concepts, cleanroom classifications, biosafety requirements, personnel and material flow strategies, and aseptic processing principles.

7.      Able to work independently in conceptual design, process equipment selection, facility planning, and technology evaluations.

8.      Should possess thorough knowledge of ISPE, PDA, WHO, FDA, EMA, USFDA and other global regulatory requirements applicable to biopharmaceutical manufacturing.

1.      knowledge of API manufacturing processes including chemical synthesis, reaction, filtration, centrifugation, drying, milling, blending, and packaging operations.

2.      knowledge in equipment selection and sizing for reactors, filters, centrifuges, dryers, mills, pressure vessels, and solvent recovery systems.

3.      Understanding of containment strategies, industrial hygiene, OEL/OEB concepts, and high-potency API facilities.

4.      Working knowledge of hazardous area classification, ATEX/NFPA principles, solvent handling systems, and explosion protection requirements.

5.      Should knowledge of API facility layout design, process flow development, hazardous area requirements, containment concepts, and process equipment selection.

6.      Should knowledge of material and personnel flow concepts, solvent handling, explosion protection techniques, and containment requirements for highly potent compounds.

7.      Able to work as an individual contributor to develop process concepts, equipment sizing, and facility layouts during feasibility and conceptual design phases.

1.      Person should be aware of OSD Manufacturing Concepts right from Molecules to Tablets/Capsules. Person is responsible for client interactions to understand their needs and requirements, creating conceptual options, presentations and getting an “buy in” from clients on an option to proceed further. He/she is also responsible for ensuring that the Company and Group’s technical policies are followed, considering any special contractual requirements.

2.      Should have knowledge on layout designing of OSD Plants and thorough understanding of various OSD Equipment along with Containment Technologies

3.      Should knowledge on Area classification and man material flow concepts. Should have t knowledge on containment techniques and should be aware of carrying out Containment Studies.

4.      Able to work as an individual contributor to select and size OSD Equipment and its accessories. Presentations to clients with little or no input from other disciplines at the Feasibility and concept phases.

5.      Should have in knowledge on latest ISPE Guidelines. Should be aware of regulatory requirements of USFDA, MHRA, and WHO etc.

Technical and speciality skills:

1. Degree in Mechanical, Chemical Engineering, or related discipline from a reputed institute along with 18+ Years of exp.
2. Expert knowledge of biopharmaceutical manufacturing processes including upstream processing (cell culture, fermentation), downstream processing (filtration, chromatography, purification), formulation, and fill-finish operations.
3. Expertise in equipment selection and sizing for bioreactors, fermenters, chromatography systems, filtration skids, buffer preparation systems, CIP/SIP systems, and single-use technologies.
4. Ability to perform process capacity calculations and facility throughput assessments.
5. Strong understanding of cleanroom classifications, contamination control strategies, biosafety requirements, and aseptic design principles.
6. Expertise in facility layouts for vaccine, monoclonal antibody, recombinant protein, and cell & gene therapy facilities.
7. Strong knowledge of process utilities including WFI, clean steam, process gases, and biopharmaceutical support systems.
8. Thorough understanding of GMP requirements, ISPE Baseline Guides, Annex 1 requirements, and current industry trends including digitalization and single-use technology applications.
9. Ability to guide project teams during GMP reviews, technology assessments, and conceptual design development.
10. Must have prior experience working with other global offices and their leads handling various equipment packages.
11. Must have experience in responding to

to technical queries and Requests for Information (RFIs) by demonstrating expertise in GMP compliance, equipment design, and validation independently, ensuring all answers are accurate, transparent, and aligned with regulatory expectations.