Validation Specialist

3 days ago

Bengaluru, Karnataka, India Elongo Global Solutions Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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
Validation Specialist

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 Specialist
will execute and support validation activities in alignment with
global quality standards and regulatory requirements
. The role requires solid expertise in
Computer System Validation (CSV)
, along with hands-on experience in
Equipment/Utility Qualification
and/or
Process, Cleaning, and Method Validation
.

The ideal candidate is
detail-oriented, compliance-driven, and capable of independently managing
validation deliverables across cross-functional teams.

Key Responsibilities

  • Execute validation protocols and reports for systems, equipment, and processes.
  • Conduct
    Installation, Operational, and Performance Qualification (IQ/OQ/PQ)
    activities.
  • Support
    risk assessments
    , gap analyses, and remediation planning.
  • Maintain documentation in accordance with
    cGMP, GAMP 5
    , and company procedures.
  • Participate in
    audits, CAPA investigations
    , and deviation resolution.
  • Collaborate with cross-functional teams to ensure timely project completion.
  • Contribute to
    SOP development and updates
    as part of continuous improvement initiatives.

Core Expertise Areas

  • Computer System Validation (CSV) – Mandatory:
    Hands-on experience with validation of
    GxP systems
    (MES, LIMS, ERP, QMS).
  • Equipment/Utility Qualification:
    Strong understanding of qualification lifecycle,
    FAT/SAT
    , and change control.
  • Process/Cleaning/Method Validation:
    Preferably for
    oral solid, topical, or spray forms
    .

Profile Requirements

  • Bachelor's or Master's degree
    in Engineering, Pharmacy, or Life Sciences.
  • 8–10 years of experience
    in pharmaceutical validation.
  • Strong working knowledge of
    GAMP 5
    ,
    FDA
    , and
    EU regulatory guidelines
    .
  • Excellent
    documentation, analytical, and organizational
    skills.
  • Self-driven, detail-oriented, and able to work effectively in a
    global matrix environment
    .

What We Offer

  • Opportunity to work on
    international validation projects and systems
    .
  • Exposure to
    multi-site operations
    and diverse regulatory frameworks.
  • Hybrid work model
    offering flexibility and work-life balance.
  • Long-term engagement with
    growth and career advancement opportunities
    .

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