Validation Manager

About Us

Elongo

is a growing and innovative organization delivering high-quality

business support and talent solutions

across diverse industries, including

pharmaceuticals, life sciences, technology, and engineering

We partner with global enterprises to provide specialized professionals and managed services that drive operational excellence and compliance.

As part of our continued growth, we are seeking an experienced and dynamic

Manager – Validation

to support our client’s pharmaceutical operations and global validation initiatives.

Location :

Hyderabad (Hybrid : 3 Days Office / 2 Days Remote)

Engagement :

18-Month Contract-to-Hire

About the Role

The

Validation Manager

will lead and oversee all validation activities across global sites, ensuring alignment with corporate quality standards and international regulatory requirements.

This role requires a strong foundation in

Computer System Validation (CSV)

CSV : Strong knowledge of

FDA,

GAMP 5

, and global regulations (

US, EU, TGA

; Japan a plus)

and broad experience in

Equipment / Utility Qualification

and / or

Process, Cleaning, and Method Validation

The ideal candidate will demonstrate strong leadership, cross-functional collaboration, and the ability to design and implement global validation strategies.

Key Responsibilities

Lead validation projects across global manufacturing and R&D facilities.

Define and implement the

Validation Master Plan

, SOPs, and global quality standards.

Ensure full compliance with

cGMP, ISO, WHO

, and applicable regulatory frameworks.

Review and approve validation protocols, reports, and risk assessments.

Manage and mentor site validation teams through

Communities of Practice (COP)

and structured training programs.

Provide strategic guidance during

audits, CAPA

, and

change control processes

Coordinate with cross-functional teams (

Quality, Engineering, Manufacturing, IT

) to ensure seamless project execution.

Drive continuous improvement initiatives to strengthen validation compliance and efficiency.

Core Expertise Areas

Computer System Validation (CSV) :

Expert knowledge of

FDA 21 CFR Part 11

Annex 11

GAMP 5

, and other global standards.

Equipment / Utility Qualification :

Strong understanding of

IQ / OQ / PQ

FAT / SAT

, and

risk-based validation

approaches.

Process / Cleaning / Method Validation :

Experience with

oral solid, topical, and spray dosage forms

preferred.

Profile Requirements

Bachelor’s or Master’s degree in

Engineering, Pharmacy, or Life Sciences

10+ years

of experience in

pharmaceutical validation

(FMCG experience less preferred).

Proven leadership experience managing

cross-functional validation teams

Strong knowledge of

global regulatory requirements

and

audit readiness

Excellent communication, documentation, and

project management skills

What We Offer

strategic leadership role

supporting a leading global pharmaceutical organization.

Exposure to

international validation frameworks

and

advanced compliance systems

Hybrid work flexibility

with a long-term

contract-to-hire

pathway.

A collaborative, growth-oriented environment within

Elongo