Role & responsibilities Experience: - 3-6 yearsResponsibilities: Lead process and automation design in ongoing project.Review consultants/ equipment suppliers documents for design, requirement and GxP compliance.Lead equipment/ system packages in facility and equipment FAT, installations, SAT, Facility start-up, Support process systems IQ/OQs, PQs, engineering batches.Prepare/ support preparation/ review of URS, DQ. Lead procurement related activities for equipment.Preferred candidate profile A degree in chemical engineering with 6-8 years of experience in design/ manufacturing/ any technical services for pharma/ biopharma facilities.Shall have knowledge of pharma GMP, ISPE, ASME BPE guidelines.Shall be proficient with operations and design of CIP and SIP. Experience in biotech plants/ experience in biotech manufacturing is highly preferred.Shall be able perform and review heat/ mass balance and utility calculations.Perks and benefits To the industry standards

Role & responsibilities Experience: - 3-6 yearsResponsibilities:Support process and automation design in ongoing project.Review consultants/ equipment suppliers documents for design, requirement and GxP compliance.Support / actively participate in facility and equipment FAT, installations, SAT, Facility start-up, IQ/OQs, PQs, engineering batches.Support preparation/ review of URS, DQ. Support procurement related activities for equipment.Preferred candidate profile A degree in chemical engineering with 3-5 years of experience in design/ manufacturing/ any technical services for pharma/ biopharma facilities.Shall have knowledge of pharma GMP guidelines.Knowledge in biotech plants/ experience in biotech manufacturing is an advantage.Shall be able to understand and perform basic heat/ mass balance and utility calculations.Perks and benefits To the industry standards

Role & responsibilities 1. Environmental Monitoring: To perform Environmental monitoring methods, including: 1. Settle plate and microbial air sampling 2. Surface monitoring (contact and swab) 3. Personnel monitoring 4. Non-viable particle count2. Data Reporting and Analysis: Collect, analyze, and report environmental monitoring data, including: 1. Plate enumeration 2. Data trending and reporting 3. Interpretation of results3. Data Integrity and Compliance: Ensure data integrity and compliance with ALCOA++ policy and regulatory requirements (EMA, USFDA, GDP, and GLP).4. Digital Platform Management: Manage and maintain environmental monitoring data using MODA/LIMS software or other digital platforms.5. Regulatory Communication: Communicate effectively with regulators and internal stakeholders regarding environmental monitoring results, deviations, and corrective actions.6. Documentation and Record-Keeping: Maintain accurate and complete records of environmental monitoring activities, including sampling, testing, and results.Preferred candidate profile 1. Education: Masters/bachelors degree in microbiology, Biology, or a related field.2. Experience: 1-4 years of experience in environmental monitoring or a related field in the pharmaceutical industry.3. Skills: 1. Strong knowledge of environmental monitoring methods and protocols. 2. Experience with data analysis, reporting, and interpretation. 3. Familiarity with regulatory requirements (EMA, USFDA, GDP, and GLP). 4. Excellent communication and problem-solving skills.

Role & responsibilities Responsible to receive, register and analyze batch samples and stability samples.Responsible to prepare reagents, buffers and test solutions as and when required.Responsible to operate, calibrate/ verify/ qualify HPLC, UPLC instruments.Responsible to execute the Analytical Method validations/verifications/Transfers Responsible to prepare SOPs, STPs, Protocols and other GMP documentsResponsible to interpret and record the data / results accurately and contemporaneously.Responsible to report to superior any abnormalities found during routine activitiesResponsible to follow Hygiene, Safety, SOPs, GLP, GMP and GDP.Preferred candidate profile Adequate testing knowledge on Biologics/Monoclonal AntibodiesCapillary Electrophoresis : CESDS-R, CESDS-NRHPLC : RP, SEC, Glycan, CEX, Ion exchange chromatography and Polysorbate 20 Maurice : charge variants by iCEFUPLC : Peptide mapping. Qualification and Experience :MSc Biotechnology/Biochemistry/Microbiology with 03-07 Years experience of Biosimilars/Biologics QC.

Role & responsibilities 1.Experience on Bio-pharmaceutical Projects / Maintenance / Operations or in Project Consulting firms. 2. Hands on Experience on Black utilities systems installation, commissioning & qualification 3. Hands on Experience on Chillers, Air compressors, Boilers, Plant steam/Hot water/Chilled water distribution systems, Biowaste treatment systems installation, commissioning &qualification 4. Hands on Experience on HVAC/Facility Systems installation, commissioning &qualification 5. Experience in process drain piping, external pipe rack systems installation & commissioning. 6. Responsible for construction quality and commissioning readiness of various utility systems. 7. Preparation, Review of Mechanical components technical specifications. 8. Responsible for execution of projects with an internal team and in coordination with consultants/contractors. 9. Preparation/Review of documents URS, P&ID, DQ, FAT, SAT, IQ, OQ. 10.Responsible for executing commissioning & qualifications (FAT, SAT, IQ, OQ) for all Utility/ HVAC in coordination with vendors/contractors and users. 11.Responsible for technical bid analysis/ design drawing review of vendor proposals. 12.Responsible for ensuring the execution of preventive and breakdown maintenance of all equipment as per applicable SOPs and Good Engineering Practices. 13.Responsible for safety compliance during construction & execution phase of project. 14.Responsible for preparation and review of engineering related SOPs 15.Responsible for handling QMS activities during project phase as well during operations. Preferred candidate profile At least 5 years handling Experience on Bio-pharmaceutical Projects / Maintenance / Operations or in Project Consulting firms.

Role & responsibilities Hands on Experience in Clean utilities systems installation, commissioning & qualification . Hands on Experience on RO systems, WFI Generation & Distribution systems, Pure Steam Generation & Distribution Systems, Gas Distribution systems installation, commissioning. Experience in process drain piping, external pipe rack systems installation & commissioning. Responsible for construction quality and commissioning readiness of various utility systems. Preparation, Review of Mechanical components technical specifications. Responsible for execution of projects with an internal team and in coordination with consultants/contractors. Preparation/Review of documents URS, P&ID, DQ, FAT, SAT, IQ, OQ. Responsible for executing commissioning & qualifications (FAT, SAT, IQ, OQ) for all Clean utility systems in coordination with vendors/contractors and users. Responsible for technical bid analysis/ design drawing review of vendor proposals. Responsible for ensuring the execution of preventive and breakdown maintenance of all equipment as per applicable SOPs and Good Engineering Practices. Responsible for safety compliance during construction & execution phase of project. Responsible for preparation and review of engineering related & Utility System Operation & Maintenance SOPs Responsible for handling QMS activities during project phase as well during operations. Preferred candidate profile At least 5 years handling Experience on Bio-pharmaceutical Projects / Maintenance / Operations or in Project Consulting firms. Perks and benefits Competitive to the market standartds