Walk-In on 30th March for Senior Executive / Sr Executive Instrumentation/Mech Engineering | Biological E | Hyderabad

Job Description

Biological E. Limited invites Dynamic & Self-motivates candidates experienced, dynamic and self-motivated candidates for the Engineering department at its Pharma SGI -USFDA Approved plant, Shamirpet, Hyderabad

JD of Instrumentation Engineer:

• Must be experienced in Sterile injectable facility and equipment.
• Responsible for scheduled activities i.e. Preventive maintenance, backup & restore, time synchronization, etc.
• Participate in instrument calibration activity.
• Hands-on experience in troubleshooting & maintenance of the following equipment:-
  • Vial filling machine (Make Steriline),
  • Vial washing machine (Make Steriline),
  • Vial depyrogenation tunnel (Make Steriline),
  • Automatic loading & unloading system (Truking),
  • Lyophilizer (Truking),
  • Vial cap sealing machine (sterilize),
  • Steam sterilizer & terminal sterilization autoclave (Fedegari),
  • Manufacturing vessel (DDE)
• Daily monitoring and documentation of Operation & Maintenance log sheets for the Instrumentation.
• Involving and executing Installation and Operational qualification protocols, compiling and archiving it with the coordination of vendors.
• Monitoring of computer system validation activities for PA, PF, and Admin.
• Responsible for preparing & training on SOPs related to instrumentation.
• Responsible for computer system admin activities for production & admin systems.
• Responsible for audit compliance related to instrumentation.
• Identify the operational issues related to instrumentation and rectify the same.
• Preparation of Basic and detailed engineering for instrumentation and automation projects.
• Involving and executing instrumentation and automation projects.
• Responsible to keep the areas and documents ready for various regulatory inspections/audits and need-based active participation during audits.
• To support the documentation related to Change Controls, CAPAs, Deviations, etc., to comply with the CGMP guidelines, and site quality procedures.
• Responsible to execute the assigned projects.
• Ensure the requirements/ principles of CGMP, CGEP, and CGDP adhere to during the execution of activities.
• Ensure safety precautions are followed during the execution of activities.

JD of Mechanical Engineer:

• Must be experienced in Sterile injectable facility and equipment.
• Hands-on experience in troubleshooting & maintenance of the following equipment:-
• Vial filling machine (Make Steriline), Vial washing machine (Make Steriline), Vial depyrogenation tunnel (Make Steriline), Automatic loading & unloading system (Truking), Lyophilizer (Truking), Vial cap sealing machine (Steriline), Steam sterilizer & terminal sterilization autoclave (Fedegari), Manufacturing vessel (DDE).
• Involving in all equipment qualifications as part of mechanical.
• Involving in the preparation of protocols along with QA.
• Involving and executing Installation and Operational qualification protocols, compiling and archiving it with the coordination of vendors.
• Verification of drawings and making as-built with the coordination of vendor.
• Responsible to maintain spares for Process equipment.
• Addressing and rectification of mechanical breakdowns.
• Follow up with vendors for project execution, maintenance, and breakdown activities.
• Responsible to prepare, SOPs, Preventive Maintenance Schedules, and Preventive Maintenance checklists for Process Equipment.
• Performing Preventive Maintenance Procedures for Production Formulation Process equipment.
• Raising and Closing Engineering Change controls, Incidents, Deviations, and CAPA, etc. coordinating with cross-functional teams to close the documents.
• Responsible for keeping the areas and documents ready for various regulatory inspections/audits.
• Responsible to impart training for the team members and Vendors
• Ensure the Requirements /Principles of CGMP, CGEP, and CGDP adhere to during the execution of activities.
• Ensure Safety precautions are followed during the execution of activities.

Department: Engineering

Position: Executive/Sr. Executive

Qualification: B.Tech with a minimum of 7 Years and Diploma with 10 years of experience.

Walk-In Details:

Date & Time:30 March, 10.00 AM – 4.00 PM

Venue:

Biological E Limited. Pharma Division,

Plot No.4, Phase-II, Alexandria Knowledge Park,

Genome Valley, Kolthur Village, Shameerpet Mandal,

R. R. District, Hyderabad,

Telangana, India.