*Role & responsibilities *Sampling Testing & of Packaging Material*SAP entry *Cross checking Of issued packaging Material to Production. Interested applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9687700982

Siemens PCS-7 Skills:*1. Programming languages: C#, STL, SCL2. PCS 7 system configuration and design3. SIMATIC IT (Industrial IT) integration4. WinCC (Windows Control Centre) visualization5. S7-300/S7-400 PLC programming6. PROFINET/ Profibus Industrial Ethernet networking*Rockwell Plant Pax Skills:*1. Programming languages: Ladder Logic, Function Block, Structured Text, LBSM2. Plant Pax system configuration and design3. ControlLogix/CompactLogix PLC programming4. FactoryTalk View SE/ME visualization5. Ethernet/IP networking*Biotech Process Automation Skills:*1. Good Manufacturing Practice (GMP) compliance2. ISA-88 (Batch Control) and ISA-95 (Enterprise-Control System Integration) standards3. Process analytical technology (PAT) integration4. Fermentation, purification, and filling processes5. Clean-in-place (CIP) and sterilization-in-place (SIP) systems6. Automated batch management and recipe Management.*General Automation Skills:*1. Process control and automation concepts2. Instrumentation and sensor technologies3. Networking protocols (TCP/IP, UDP, etc.)4. Data analytics and visualization tools5. Troubleshooting and debugging techniques6. Version control systems (e.g., TIA Portal, RS Logix)7. Building Management System - Sauter*Soft Skills:*1. Problem-solving and analytical thinking2. Time management and organization3. Documentation and reporting4. Teamwork and collaboration5. Adaptability and continuous learning*Certifications:*1. Siemens Certified PCS 7 Engineer2. Rockwell Automation Certified Integrator3. Certified Automation Professional (CAP)4. Certified Control Systems Technician (CCST)*Education:*1. Bachelor's degree in Instrumentation or E & TC Engineering2. Master's degree or Ph.D. in Automation, Control Systems, or related field (optional)*Experience:*1. Minimum 5 years of experience in automation engineering2. Experience with Siemens PCS-7 and Rockwell Plant Pax systems3. Experience in biotech or pharmaceutical industries*Industry Knowledge:*1. Biotech and pharmaceutical manufacturing processes- FDS, IQ, OQ2. GMP, FDA, and EU regulations , 21 CFR Part -113. Industry standards (e.g., ISA-88, ISA-95)4. Safety and regulatory requirements (e.g., SIL, HazLoc)*Tools and Software:*1. TIA Portal2. RS Logix Studio 50003. FactoryTalk View4. WinCC5. SIMATIC IT6. PROFINET/Industrial Ethernet7. configuration tools7. Sauter BMS system8. SQL9. Zenon SCADA10. Historian11. VFD configuration12. Festo Ethernet Valve terminal13. Kepware OPC

Roles and ResponsibilitiesConduct microbial testing, environmental monitoring, validation, and qualification activities to ensure compliance with regulatory requirements.Review and approve batch records for release of products into market, ensuring accuracy and completeness of data.Perform root cause analysis for deviations and non-conformities, implementing corrective actions to prevent recurrence.Collaborate with cross-functional teams to resolve issues related to product quality, manufacturing processes, or regulatory affairs.Ensure adherence to cGMP guidelines and company policies throughout all aspects of work.

Freshers

JD .SAP Implementation (B1 or S4 Hana) Perks.Free Pickup and Drop Service and Canteen Facility.Interested Applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9867700982

1. Equipment Expertise: Possess in-depth knowledge of both upstream and downstream equipment, including fermenters, centrifuges, homogenizers, lyophilizers, agitator vessels, heat exchangers, pumps, valves, and filtration systems.2. Process Knowledge: Demonstrate a solid understanding of fermentation, filtration, lyophilization, and cooling and heating systems used in production processes.3. Deviation Management: Handle deviations related to equipment failures and conduct risk evaluations for process equipment to ensure smooth operations.4. Continuous Improvement: Drive continuous improvement in maintenance activities and implement corrective and preventive actions (CAPA) to enhance equipment reliability and operational efficiency.5. Project Management: Lead and manage process modification projects, ensuring timely and successful completion of enhancements and upgrades.6. Compliance & Standards: Ensure operations adhere to cGMP, GEP, and GDP standards to maintain quality and regulatory compliance across all processes.7. SAP Implementation: Contribute to SAP implementation projects and manage maintenance and breakdown activities in SAP to streamline operations and improve tracking.8. Quality Management: Utilize hands-on experience with QMS (Quality Management Systems) to ensure quality control and consistent product standards.9. Financial Management: Oversee Opex (Operational Expenditure) and Capex (Capital Expenditure) budgets, ensuring cost-effective solutions for equipment maintenance and upgrades.10. Team Leadership: Lead, manage, and mentor teams, fostering a collaborative environment to enhance performance and meet operational objectives.11. Training: Provide training to staff on equipment operation, safety procedures, and best practices for maintaining compliance with industry standards.12. Utilities Management: Possess comprehensive knowledge of utilities equipment, including chillers, HVAC systems, N2 compressors, and cooling towers, ensuring proper operation and maintenance.13. Modification & Expansion Projects: Lead modifications, expansions, and capacity enhancement projects, ensuring that they align with operational goals and efficiency improvements.Operational Excellence: Demonstrate expertise in OEE (Overall Equipment Effectiveness), LSS (Lean Six Sigma), and energy-saving initiatives to drive productivity, reduce waste, and optimize energy use across operations.

Role & responsibilities Contractual Role for 6 Months.Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format.Internal communication & follow-ups with various departments for various documents.To arrange and send samples for registration purpose to various countries.Review at all quality data received from various departments before using in dossiers and technical packages.Preparation and submission of Query response raised by the Health Authority.To undertake any other assignment given by superior of the department / management from time to time.To support in documentation in national and international tenders.Management of Product Database. Archival of dossier.For COPP Application- Support with documents. Preferred candidate profile Must be from Formulation background interested applicant can send CV on shital@mjbiopharm.com , janhavi.shedekar@mjbiopharm.com or contact on 9619744167.Perks and benefits

The Purchase Executive will be responsible for managing the procurement process for raw materials, packaging materials, and other supplies required for the sterile plant operations in the pharmaceutical industry. The role includes vendor management, cost-effective purchasing, ensuring quality and compliance with regulatory standards, and maintaining inventory levels to support production schedules.Key Responsibilities:Vendor Management:Identify and evaluate potential suppliers.Negotiate contracts, terms, and pricing with suppliers.Maintain strong relationships with existing suppliers to ensure reliable supply chains.Procurement Process:Source and procure raw materials, packaging materials, and other supplies required for sterile plant operations.Ensure timely delivery of materials to meet production schedules.Conduct market research to stay updated on industry trends and pricing.Quality Assurance:Ensure that all procured materials meet quality standards and regulatory requirements.Coordinate with the Quality Assurance team to resolve any quality-related issues.Inventory Management:Monitor inventory levels to avoid stockouts or overstocking.Implement inventory control measures to optimize stock levels and reduce waste.Documentation and Compliance:Maintain accurate records of all procurement activities.Ensure compliance with all regulatory requirements related to procurement and supply chain management.Cost Management:Identify cost-saving opportunities without compromising on quality.Prepare and manage budgets for procurement activities.Coordination and Communication:Collaborate with various departments such as Production, Quality Control, and Finance to ensure smooth operations.Communicate effectively with internal and external stakeholders.Qualifications:Bachelors degree in Supply Chain Management, Business Administration, or a related field.Minimum of 3-5 years of experience in procurement, preferably in the pharmaceutical industry.Knowledge of sterile manufacturing processes and regulatory requirements.Strong negotiation and communication skills.Proficiency in procurement software and Microsoft Office Suite.Ability to work in a fast-paced environment and manage multiple tasks simultaneously.Preferred Skills:Experience with SAP systems.Certification in Supply Chain Management (e.g., CSCP, CPSM).Working Conditions:Office environment with occasional visits to the sterile plant and supplier locations.Some travel may be required.Application Process:Interested candidates should submit their resume on janhavi.shedekar@mjbiopharm.com or contact on 9867700982.

Role & responsibilities 1. Experience in Batch Preparation.2. Batch Filling.3. Aseptic Maintenance.4. Media FIll.5. Validation.Preferred candidate profile From sterile formation injectable plant.Perks and benefits 1. Pickup and Drop Facility2. Canteen Facility

Role & responsibilities 1. Line Clearance in all stages.2. Sampling all stages.3. Validation.4. Control Sample Management5. APQR6. QMS Review.Interested Applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9867700982

Sr. Officer Accounts | Role & responsibilities Data entry in SAP BI e.g A/P, A/R InvoicesBasic GST/ TDS Data preparationCommunication with Depts./ Vendor for bills/ Ledgers etc.Documentation Related to A/C EntriesBasic MIS Reports in excel.Interested Applicant can send CV on " janhavi.shedekar@mjbiopharm.com or contact on "9867700982"

Roles and Responsibilities - Vial Operator1. Operate the Vail/ Cartridge filling Machine.2. Operate the Vail/Cartridge Washing and Tunnel3. Having Knowledge in Aseptic Operation4. Operate the Autoclave5. Knowledge in Equipment preparation.Desired Candidate Profile Must have worked in Sterile injectable Plant.Interested Applicant can send their CV on janhavi.shedekar@mjbiopharm.com or contact on 9619744167.

1. Equipment Expertise: Possess in-depth knowledge of both upstream and downstream equipment, including fermenters, centrifuges, homogenizers, lyophilizers, agitator vessels, heat exchangers, pumps, valves, and filtration systems.2. Process Knowledge: Demonstrate a solid understanding of fermentation, filtration, lyophilization, and cooling and heating systems used in production processes.3. Deviation Management: Handle deviations related to equipment failures and conduct risk evaluations for process equipment to ensure smooth operations.4. Continuous Improvement: Drive continuous improvement in maintenance activities and implement corrective and preventive actions (CAPA) to enhance equipment reliability and operational efficiency.5. Project Management: Lead and manage process modification projects, ensuring timely and successful completion of enhancements and upgrades.6. Compliance & Standards: Ensure operations adhere to cGMP, GEP, and GDP standards to maintain quality and regulatory compliance across all processes.7. SAP Implementation: Contribute to SAP implementation projects and manage maintenance and breakdown activities in SAP to streamline operations and improve tracking.8. Quality Management: Utilize hands-on experience with QMS (Quality Management Systems) to ensure quality control and consistent product standards.9. Financial Management: Oversee Opex (Operational Expenditure) and Capex (Capital Expenditure) budgets, ensuring cost-effective solutions for equipment maintenance and upgrades.10. Team Leadership: Lead, manage, and mentor teams, fostering a collaborative environment to enhance performance and meet operational objectives.11. Training: Provide training to staff on equipment operation, safety procedures, and best practices for maintaining compliance with industry standards.12. Utilities Management: Possess comprehensive knowledge of utilities equipment, including chillers, HVAC systems, N2 compressors, and cooling towers, ensuring proper operation and maintenance.13. Modification & Expansion Projects: Lead modifications, expansions, and capacity enhancement projects, ensuring that they align with operational goals and efficiency improvements.Operational Excellence: Demonstrate expertise in OEE (Overall Equipment Effectiveness), LSS (Lean Six Sigma), and energy-saving initiatives to drive productivity, reduce waste, and optimize energy use across operations.

Preferred candidate profile***Biologics experience mandatory Role & responsibilitiesLiterature survey for Regulated and other markets drug products and other activities for complete dossier as per regulatory requirement for Formulation Development of new biological injectable formulation.Plan and monitor pre-formulation studies for biological products if needed along with innovator products characterization through subordinate scientist.Plan and monitor lab trials through subordinate scientist for formulation development of new biological injectable formulation projects as per product development timelines.To review analytical data and compile generated during different stages of formulation development of new biological products.To plan and execute along with subordinate scientist R & D scale up, plant scale up, Tech transfer batches, exhibit batches and validation batches as tech transfer activities in manufacturing location of new biological injection formulations as per regulatory requirements.To coordinate with CMOs (Contract Manufacturing Organization) for planning and executing external Tech transfer activities in manufacturing location of new biological injection formulations as per regulatory requirements.Provide technical support to production during execution of commercial validation and for any trouble shooting during production.Coordinate and support to Regulatory affairs team regarding product filing, query response and life cycle managements activities.Maintain stability record, responsible for stability data compilation and planning.Prepare of SOPs, PDR, BMR, MFR, stability protocol, stability report, process optimization protocol and report, TT protocol & Report, PV protocol & report.Monitor & maintain the store inventory for API, excipients and packaging material.Prepare and maintain of proper batch records, LNBs with all the compilation from F&D and ADL during product development.Perform activities related to new product regulatory filing and query response.Responsible to maintain good documentation practices, good lab practices and adherence to SOPs in Formulation Development Department.Perks and benefits