ITSoli - LIMS Validation Engineer - ELN/Biovia - bangalore, India - ITSoli India Private Limited

ITSoli India Private Limited bangalore, India

1 week ago

Technology / Internet

Description

Job Title : LIMS Validation Engineer

Department : Lab Info Systems - US001

Qualification : BS in Engineering, Science or equivalent technical degree.

Work Location : Bangalore (Karnataka)

Work Mode : Hybrid (Should be ready to work from office as in when required)

Work Timing (PST hours) : 7:00 PM - 4:00 AM / 8:30 PM - 5:30 AM : Best in the Industry (Negotiable as per Industry Standards)

Job Summary :

As a LIMS Validation Engineer, you will be responsible for the validation, qualification, and compliance of the Laboratory Information Management System (LIMS). You will collaborate with cross-functional teams to ensure that the LIMS software meets regulatory standards, operational requirements, and quality standards.

Your role will involve designing and executing validation protocols, documenting validation activities, and ensuring that the LIMS functions reliably and efficiently.

Required experience :

a) 3+ years validation of Laboratory (analytical equipment / software)

b) 2+ years of work experience with any LIMS Data Analytics Software application (SoftMax Pro, GLIMS, LabX, Labware, Empower, Biovia, Discoverant, ELN, ELS).

c) Familiar with software development life cycle

d) Working knowledge of FDA and cGMP regulations and documentation practices

Job Responsibilities :

1. Writes, reviews and revises a variety of installation, operation and performance qualification/verification related documents, including any of all of the following : SOPs, validation/verification master plans, guidelines and execution plans, qualification or other technical documents, user requirement specifications (URS), Design specifications (DS), functional requirement specifications (FRS) and verification protocols

2. Provide assistance in drafting the validation protocols (IQ, OQ, PQ) for systems and processes for qualification/ verification and/ or re-qualification/ re-verification.

3. Writes and executes protocols, assist in drafting the deviations/discrepancies and draft summary reports.

4. Writes reports to summarize Validation/verification and/or re-validation/verification activities.

5. Responsible for drafting change control documents.

Key Requirements :

1. 3+ year experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.

2. Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation protocols (IQ, OQ, PQ, PV, CV, CSV, etc), Quality Systems (Change Control, Non-conformances, Re-qualification, etc) and Process Excellent Methodologies (Six Sigma, Lean, etc).

3. Excellent written and verbal communication skills; excellent technical writing skills.

4. Strong interpersonal skills and the ability to work in a team environment.

5. Ability to work effectively in a fast-paced multitasking environment.

6. Strong working knowledge of FDA and cGMP regulations and documentation practices.

7. Proficient in Microsoft Word, Excel, PowerPoint.

8. Working for multiple clients throughout the region.

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