MSD India Hiring For Lab Automation Specialist Vacancy – Biology & Microbiology Candidates Apply. MSD BS Biology, Microbiology Lab Automation Specialist job opening. Interested and eligible applicants can check out all of the details on the same below
Post Name – Manager – Lab Automation Specialist
Location – Pune, Maharashtra, India
Job Description
Lab Automation Specialist
Description
The Lab Automation Specialist is responsible for supporting the development and management of validated excel workbooks used in the regulatory environment to support Laboratory testing. The candidate should have
- Experience with VBA programming and developing excel formulas.
- Knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
- Processes change controls following applicable procedures and documents changes in an electronic repository.
- The projects assigned are technical in nature and require a working knowledge of analytical testing methods and GMP Compliance.
- Ensure on time implementation of workbook changes through collaboration with business areas in support of requirements definition, functional design, and configuration.
- Provides second person review support for team members change control documents to source documents to ensure accuracy, compliance, integrity, and completeness.
- Experience with authoring test protocols to validate the change based on requirements and design, and execution of test scripts. Familiarity with electronic testing tools (eVal or other) is preferred.
- Experience with use of LIMS (Labware LIMS v6 or higher, or other) including but not limited to knowledge of developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, standard and Reagent, and instrument manager.
Qualifications
Minimum Education Requirement:
- Bachelor’s Degree or higher in Computer Science, BS Biology, Microbiology, Pharmacy, Chemistry, Engineering or demonstration of the applicable experience
Minimum Requirement:
- A minimum of 2 years of experience in VBA programming for development/validation of Microsoft Excel workbooks for GMP use in regulated environment.
- Familiarity with LIMS to support Release testing, Stability, and Environmental Monitoring.
- Candidate must have knowledge of regulatory expectations for the manufacture and testing of vaccines, biological products, or sterile pharmaceutical products.
- Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
- Ability to write test scripts and support execution of validation protocols adhering to SDLC.
- Incumbent must complete technical assignments independently once specific objectives have been defined.
- Possesses a technical aptitude for computerized systems, analytics, and method evaluations.
- Flexible working hours (up to ~25%/week) are required to support collaboration with project teams in US East coast, especially during initial training period.
Preferred Experience and Skills:
- Familiarity with other compliant industry platforms/systems, electronic document management systems, change control systems.
- Experience in Labware LIMS (v6 or higher) master data management.
- Use of databases, Oracle, data trending and basic coding capability (such as SQL, VBA)