CSV Documentation Trainee / Validation Documentation Associate

JOB DESCRIPTION

Position

CSV Documentation Trainee / Validation Documentation Associate

Location

Remote / Hybrid

Job Type

Full-Time

About SAS Automation

SAS Automation is a leading engineering and industrial automation company providing solutions in Process Automation, SCADA, IIoT, Energy Management Systems (EMS), Building Management Systems (BMS), and Computer System Validation (CSV) for pharmaceutical, biotechnology, and regulated industries. With a growing presence across India and international markets, SAS Automation delivers innovative and compliant solutions to customers worldwide.

At SAS Automation, we believe in nurturing young talent and providing opportunities for continuous learning and professional growth. We offer structured training, mentorship from experienced professionals, and exposure to global projects. Candidates joining our organization can build rewarding careers in Life Sciences, Validation, Quality, and Regulatory Compliance domains.

We foster a culture of innovation, integrity, teamwork, and excellence, enabling employees to grow along with the organization and achieve long-term career success.

About the Role

We are looking for motivated and detail-oriented freshers to join our Computer System Validation (CSV) team. The selected candidates will support documentation, quality records management, validation documentation preparation, and compliance activities for regulated pharmaceutical and biotechnology projects.

This role is ideal for candidates with strong English communication, documentation, and report-writing skills who are interested in developing a career in the Life Sciences, Quality, and Regulatory Compliance domain.

Educational Qualification

· B.A. English

· B.Sc. English

· M.A. English

· Freshers are encouraged to apply

· Strong written and verbal communication skills

· Good knowledge of MS Word, Excel, PowerPoint, and Outlook

Key Responsibilities

Sr. No.

Responsibility

Description

1

Validation Documentation Preparation

Prepare, format, review, and maintain validation documents as per regulatory and company standards.

2

Protocol Development Support

Assist in preparing URS, FS, DS, IQ, OQ, and PQ protocols and reports.

3

Document Control

Maintain document templates, revision history, and validation records.

4

Project Documentation Support

Support senior CSV engineers in project documentation activities.

5

SOP Preparation

Assist in preparing SOPs, work instructions, forms, and training documents.

6

Compliance Activities

Ensure adherence to document control procedures and GxP requirements.

7

Deliverable Tracking

Maintain project status logs and track documentation deliverables.

8

Quality Review Support

Participate in quality review meetings and project discussions.

9

Audit Readiness

Support audit and inspection readiness activities.

10

Cross-Functional Coordination

Coordinate with QA, IT, Engineering, and Validation teams.

11

Documentation Archival

Organize and maintain project records and quality documents.

12

Continuous Learning

Develop knowledge of pharmaceutical regulations and industry practices.

Required Skills

· Excellent English writing and communication skills.

· Strong grammar and document formatting abilities.

· Good attention to detail.

· Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

· Good organizational and time management skills.

· Ability to learn pharmaceutical compliance requirements.

· Strong analytical and problem-solving skills.

· Ability to work independently and in a team environment.

Preferred Skills

· Technical writing knowledge.

· Exposure to pharmaceutical or healthcare industries.

· Understanding of documentation lifecycle.

· Familiarity with ISO, GMP, GxP, or quality systems.

· Knowledge of quality management principles is an added advantage.

Training Provided

Selected candidates will receive structured training on:

· GxP Fundamentals

· FDA 21 CFR Part 11

· EU Annex 11

· GAMP 5 Basics

· Computer System Validation (CSV)

· Data Integrity (ALCOA+)

· Pharmaceutical Documentation Practices

· Change Control Management

· Deviation Management

· CAPA Management

· Good Documentation Practices (GDP)

· Audit and Inspection Readiness

Work Timing

During training and project support, candidates may be required to work in US shift hours based on project requirements.

Reporting Structure

Reporting To: Senior CSV Engineer / Validation Lead

Career Path

CSV Documentation Trainee

↓

Validation Documentation Associate

↓

CSV Engineer

↓

Senior CSV Engineer

↓

Validation Lead

↓

Validation Manager

Compensation & Benefits

· Competitive Salary

· Provident Fund (PF)

· Work From Home Opportunity

· Performance-Based Growth

· Annual Performance Appraisal

· Training and Certification Support

· Exposure to International Pharmaceutical Projects

· Mentorship from Experienced CSV Professionals

· Opportunity to Work with Global Regulatory Standards

· Fast-Track Career Growth for High Performers

Why Join SAS Automation?

· Opportunity to build a career in the Life Sciences and Pharmaceutical Compliance domain.

· Learn directly from experienced validation professionals.

· Exposure to FDA, EU GMP, and GAMP 5 regulatory frameworks.

· Work on challenging projects with leading pharmaceutical and biotechnology companies.

· Structured training and continuous learning environment.

· High-growth opportunities based on performance and capability.

· Collaborative and employee-focused work culture.

Together, we are building the future of automation, compliance, and digital transformation.