Executive, Pharmaceutical Validation

Key Responsibilities
You will support validation activities across facilities, utilities, equipment, and systems within a sterile pharmaceutical environment.

1. Facility & Utility Validation

Execute performance qualification (PQ) for cleanroom HVAC systems in compliance with EU GMP Annex 1 sterile requirements

Perform validation for utilities including Purified Water (PW), Water for Injection (WFI), clean steam, compressed air, and nitrogen systems

Support SIP qualification activities

2. Equipment Qualification

Perform qualification of manufacturing equipment including autoclaves, depyrogenation tunnels, vial washing machines, filling & sealing machines, and isolators/RABS

Execute IQ, OQ, and PQ protocols

Prepare traceability matrices

3. Computer System Validation (CSV)

Validate GxP systems such as BMS and EMS

Support risk assessments and validation lifecycle documentation

4. Cross-Functional Coordination

Coordinate with Engineering, Production, QC, QA, and Project teams

Support technology transfer activities

Assist in deviation investigations and CAPA implementation

5. Compliance & Documentation

Ensure validation and qualification documents are properly maintained in compliance with cGMP and GDPMD requirements

Support audit readiness and regulatory inspections

Perform any additional duties assigned by management

Requirements
Qualifications

Bachelor’s Degree in Pharmacy, Biotechnology, Chemical Engineering, or related field

Additional certification in GMP or Validation is an added advantage

Experience

Minimum 3 years of experience in pharmaceutical validation

Experience in sterile or injectable manufacturing environment is preferred

Exposure to audits and regulatory inspections

Knowledge of Quality Risk Management (QRM)

Experience in greenfield projects is an advantage

Technical Skills & Knowledge
Strong understanding of sterile manufacturing processes

Knowledge of aseptic process validation and media fills

Hands-on experience with HVAC qualification and cleanroom standards

Familiarity with EU GMP Annex 1 (latest revision)

Strong documentation and report writing skills

Risk-based validation approach

Good analytical and problem-solving skills

Competencies
Good communication and teamwork skills

Ability to work across multiple departments

Detail-oriented with strong compliance mindset

Eager to learn and develop professionally