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TRPD-26-04913
Validation Specialist / Validation Lead (Pharma/FMCG, cGMP, CSV)
Senior Validation Specialist (10–15 years) to strengthen validation governance across global FMCG/pharma operations. The role will design and execute validation/qualification protocols (IQ/OQ/PQ), author validation reports and core documentation, and develop/maintain validation standards, SOPs, and Validation Master Plans. Must have hands-on experience across process, cleaning, equipment, utilities, laboratory/analytical method validation, and Computer System Validation (CSV), working in regulated environments aligned to cGMP, FDA, WHO, ISO, and GAMP 5, with a proven track record leading site-level or multi-site validation projects end-to-end.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Full Time
- Experience
- Minimum 10 years and Maximum 15 years
Role overview
Why This Role Matters.
Senior Validation Specialist (10–15 years) to strengthen validation governance across global FMCG/pharma operations. The role will design and execute validation/qualification protocols (IQ/OQ/PQ), author validation reports and core documentation, and develop/maintain validation standards, SOPs, and Validation Master Plans. Must have hands-on experience across process, cleaning, equipment, utilities, laboratory/analytical method validation, and Computer System Validation (CSV), working in regulated environments aligned to cGMP, FDA, WHO, ISO, and GAMP 5, with a proven track record leading site-level or multi-site validation projects end-to-end.
Your Impact
Deliver Enterprise Value
Help organisations solve complex business problems through modern technology, consulting expertise and measurable outcomes.
Collaboration
Work Across Teams
Collaborate with consultants, architects, engineers and client stakeholders throughout the project lifecycle.
Growth
Learn Continuously
Gain exposure to enterprise technologies, certifications, mentoring and real-world project experience.
Career Path
Grow With Ubique
Build a long-term consulting career with opportunities to take on greater responsibility and leadership over time.
Responsibilities
What You'll Be Doing.
Every role at Ubique contributes directly to solving meaningful business challenges for our clients.
02
Direct experience designing and executing validation protocols (IQ/OQ/PQ)
03
Proven experience writing validation reports and core validation documentation
04
Experience developing and maintaining validation standards, SOPs, and validation master plans
05
Demonstrated work under cGMP, FDA, WHO, ISO, and GAMP 5 requirements in regulated environments
06
Proven track record leading and managing site-level or multi-site validation projects (planning, execution, documentation)
07
Process validation
08
Cleaning validation
09
Equipment qualification
10
Utility validation
11
Laboratory/analytical method validation
12
Computer system validation (CSV)
Technology stack
Tools & Technologies.
The platforms and technologies you'll use to build modern, enterprise-grade solutions.
01
IQ
Required
02
OQ
Required
03
PQ
Required
04
Validation Master Plan
Required
05
VMP
Required
06
SOP
Required
07
cGMP
Required
08
FDA
Required
09
WHO
Required
10
ISO
Required
11
GAMP 5
Required
12
Process Validation
Required
13
Cleaning Validation
Required
14
Equipment Qualification
Required
15
Utility Validation
Required
16
Analytical Method Validation
Required
17
Laboratory Validation
Required
18
Computer System Validation
Required
19
CSV
Required
Requirements
Skills & Experience.
We value curiosity, collaboration and continuous learning. If you don't meet every requirement but believe you can make an impact, we'd still love to hear from you.
Essential
Required Qualifications
10–15 years validation experience in pharmaceutical and/or FMCG regulated environments
Designing and executing validation/qualification protocols (IQ/OQ/PQ)
Writing validation reports and core validation documentation
Developing and maintaining validation standards, SOPs, and Validation Master Plans (VMP)
Working under cGMP requirements
Compliance exposure to FDA requirements
Compliance exposure to WHO requirements
Compliance exposure to ISO requirements
Compliance exposure to GAMP 5 requirements
Leading and managing site-level or multi-site validation projects (planning, execution, documentation)
Hands-on Process Validation
Hands-on Cleaning Validation
Hands-on Equipment Qualification
Hands-on Utility Validation
Hands-on Laboratory / Analytical Method Validation
Hands-on Computer System Validation (CSV)
Preferred
Nice to Have
There are no additional preferred qualifications for this position. If you meet the essential requirements, we encourage you to apply.
What you'll gain
More Than Just A Job.
We're committed to helping every team member grow professionally, personally and technically while working on meaningful projects.
Global Exposure
Collaborate with international clients and multicultural teams on enterprise programmes.
Continuous Learning
Expand your expertise through mentoring, certifications and hands-on project experience.
Career Growth
Take ownership, develop leadership skills and grow your consulting career over time.
Flexible Working
Hybrid and remote collaboration designed around trust and delivering exceptional outcomes.
People First
Join a supportive culture where collaboration, respect and long-term relationships come first.
Enterprise Projects
Work on meaningful technology initiatives for leading organisations across industries.
Apply
Apply for Validation Specialist / Validation Lead (Pharma/FMCG, cGMP, CSV)
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