We are hiring on behalf of our fast-growing client in the pharmaceutical validation consulting space.
Position: Validation Engineer / Senior Validation Engineer (CQV & CSV)
Location: Ahmedabad
Industry: Pharmaceutical / Life Sciences
Employment Type: Full-time
Work Mode: Onsite with partial work-from-home flexibility
Open Positions
- Validation Engineer: 3–5 years of relevant experience
- Senior Validation Engineer: 5–7 years of relevant experience
Job Summary
We are seeking qualified professionals for the role of Validation Engineer / Senior Validation Engineer (CQV & CSV) with relevant experience in the pharmaceutical industry. The selected candidates will be responsible for executing and managing validation activities, ensuring compliance with regulatory requirements, and supporting client engagements at onsite locations.
Key Responsibilities
1. Commissioning, Qualification & Validation (CQV)
- Execute and/or lead qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, and facilities
- Support commissioning activities and resolve issues encountered during execution
- Ensure adherence to applicable GMP/GxP guidelines
2. Computer System Validation (CSV)
- Perform validation of computerized systems in accordance with GAMP 5 guidelines
- Execute validation protocols and document test results
- Ensure compliance with data integrity requirements and 21 CFR Part 11
3. Onsite Execution and Client Coordination
- Carry out validation activities at client locations
- Act as a point of contact for client coordination during project execution
- Collaborate with internal teams, clients, and vendors to ensure timely project delivery
4. Documentation and Compliance
- Prepare, review, and/or approve validation documentation, including:
- Validation Plans
- User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS)
- Risk Assessments
- IQ/OQ/PQ protocols and reports
- Review client documentation to ensure compliance with regulatory standards
- Maintain audit-ready documentation
5. Equipment and Utilities Validation
- Perform qualification of manufacturing equipment and process systems
- Validate utilities such as HVAC, purified water (PW), water for injection (WFI), compressed air, and clean steam
- Identify deviations and support implementation of Corrective and Preventive Actions (CAPA)
Role Differentiation
Validation Engineer (3–5 Years):
- Execute validation activities under guidance
- Support documentation preparation and onsite activities
- Assist in troubleshooting and compliance checks
Senior Validation Engineer (5–7 Years):
- Lead validation projects and client interactions
- Review and approve validation documentation
- Provide technical guidance to junior team members
- Ensure timely and compliant project execution
Qualifications
- Bachelor's degree in Engineering, Pharmacy, Life Sciences, or a related discipline
- Relevant experience in CQV and CSV within the pharmaceutical or life sciences industry
Key Competencies
- Strong understanding of GMP, GxP, and validation lifecycle
- Knowledge of GAMP 5 and risk-based validation approaches
- Familiarity with data integrity principles and regulatory compliance
- Effective stakeholder management and communication skills
- Strong analytical and problem-solving abilities
Preferred Qualifications
- Experience working in consulting environments or across multiple client sites
- Exposure to systems such as MES, LIMS, ERP, or SCADA
- Experience in supporting audits and regulatory inspections
