Microbiologist

**Job Title: Microbiologist**

**Department**: Quality Control / Research & Development (R&D)

**Reports To**: Head of Quality Control / Laboratory Manager

**Location**: B-210, Okhla Industrial Area, Phase-I, New Delhi-110020, India

**Job Purpose**:
To perform microbiological testing, validation, and analysis to ensure the sterility, safety, and compliance of DeVine MediTech’s ophthalmic medical devices, instruments, and consumables with international regulatory standards.

**Key Responsibilities**:
**1. Microbiological Testing & Analysis**:

- Perform routine microbiological tests on ophthalmic products (e.g., intraocular lenses,
- consumables, OVDs) to ensure sterility and microbial limits.
- Conduct environmental monitoring (air, surface, and water quality) for cleanroom operations.
- Perform bioburden testing, sterility tests, endotoxin assays, and growth promotion tests.

**2. Quality Assurance & Compliance**:

- Ensure compliance with GMP, GLP, ISO 13485, and other international regulatory standards for medical devices.
- Document and validate microbiological test methods and results.
- Collaborate with the Quality Assurance team to prepare for audits (internal and external).

**3. Product Safety & Validation**:

- Test and validate ophthalmic consumables (e.g., syringes, cannulas, artificial eyes) for microbial contamination.
- Conduct stability studies and sterility validation for intraocular lenses and surgical consumables.
- Analyze trends and data to ensure products meet safety and regulatory specifications.

**4. Documentation & Reporting**:

- Maintain accurate laboratory records, test reports, and protocols as per ISO and FDA requirements.
- Prepare detailed reports and summaries for internal stakeholders and regulatory submissions.

**5. Equipment Management**:

- Operate and calibrate microbiological lab equipment (autoclaves, incubators, laminar airflow hoods, microscopes, etc.).
- Ensure regular maintenance and validation of laboratory instruments.

**6. Continuous Improvement**:

- Identify areas for process improvement to enhance testing efficiency and compliance.
- Assist R&D teams in the development of new sterilization techniques and microbiological protocols.

**Required Skills & Competencies**:

- Proficiency in microbiological techniques (sterility testing, endotoxin assays, bioburden analysis, microbial identification).
- Strong knowledge of GMP, GLP, and ISO 13485 regulations for medical devices.
- Ability to handle cleanroom operations and aseptic techniques.
- Experience with microbial validation processes (e.g., cleanroom monitoring, growth promotion testing).
- Strong documentation, analytical, and problem-solving skills.
- Proficiency in laboratory software and reporting systems.

**Educational Qualifications**:

- Bachelor’s / Master’s Degree in Microbiology, Biotechnology, or Life Sciences.
- Certifications in GMP/GLP or ISO 13485 will be an added advantage.
- Experience: 2-5 years of experience in microbiology, preferably in the medical devices, pharmaceuticals, or healthcare industry.
- Experience with ophthalmic products or sterile consumables will be preferred.

**Key Performance Indicators (KPIs)**:
1. Accuracy and timeliness of microbiological test results.

2. Compliance with sterility and regulatory requirements (ISO 13485, FDA).

3. Cleanroom environmental monitoring and reporting.

4. Successful validation of microbiological testing protocols.

5. Audit readiness and documentation accuracy.

Pay: ₹11,197.80 - ₹71,737.95 per month

**Benefits**:

- Health insurance
- Paid sick time
- Provident Fund

Schedule:

- Morning shift

Supplemental Pay:

- Commission pay
- Overtime pay
- Performance bonus
- Quarterly bonus
- Shift allowance
- Yearly bonus

**Experience**:

- Microbiology: 1 year (preferred)

Work Location: In person