Operations and Engineering Support Specialist
1 week ago
We are seeking a highly skilled Operations and Engineering Support Specialist to join our team at Biocon Biologics. This role will play a crucial part in ensuring the smooth operation of our facilities and equipment, while also contributing to the development of engineering-related documentation.
About UsBiocon Biologics is a leading global biotechnology company with a strong commitment to innovation and quality. We are dedicated to developing and manufacturing high-quality biologics that improve human health.
Job DescriptionThe Operations and Engineering Support Specialist will be responsible for preparing and executing equipment qualification documents and activities, as well as area validation documents and activities. They will also prepare documentation related to the engineering department, such as SOPs, quality and EHS management documents, and work permits. Additionally, they will issue work permits, prepare layouts related to facility, equipment, and area, and raise/take change control, deviation, and CAPA related to the engineering department.
The successful candidate will have a strong understanding of standard operating procedures, safety, cGMP, and EHS requirements, and will be able to implement and follow SAP in the department. They will also be responsible for coordinating audits (internal and external) related to QMS and EHS management systems, ensuring all audit findings are closed within the stipulated time, and performing required documentation like checklist and logbook updation.
Responsibilities:- Prepare and execute equipment qualification documents and activities.
- Prepare and execute area validation documents and activities.
- Prepare documentation related to the engineering department.
- Issue work permits.
- Prepare layouts related to facility, equipment, and area.
- Raise/take change control, deviation, and CAPA related to the engineering department.
- Implement and follow SAP in the department.
- Coordinate audits (internal and external) related to QMS and EHS management systems.
- Ensure all audit findings are closed within the stipulated time.
- Perform required documentation like checklist and logbook updation.
To succeed in this role, you will need:
- A strong understanding of standard operating procedures, safety, cGMP, and EHS requirements.
- Excellent communication and organizational skills.
- Ability to work effectively in a team environment.
- Strong problem-solving skills.
- Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
- Familiarity with SAP or similar software.
We offer a competitive salary of ₹12,00,000 - ₹18,00,000 per annum, depending on experience, plus benefits including medical insurance, retirement plan, and opportunities for professional growth and development.
If you are a motivated and detail-oriented individual who is passionate about operations and engineering, we encourage you to apply for this exciting opportunity.
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