Job Title : Validation Engineer

Department : Lab Info Systems - US001

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

Office Location : Indiranagar (Bangalore, Karnataka)

Work Mode : Hybrid (Should visit office for meetings as in when required)

Work Timing (PST hours) : 7:00 PM - 4:00 AM/8:30 PM - 5:30 AM (IST)

Salary : Best in the Industry

Required experience :

- 4+ years validation of analytical equipment / software

- 2+ years of work experience with SoftMax Pro system / equivalent Lab Info System.

- Familiar with software development life cycle

- Working in a GMP environment

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. 4+ 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.