Senior Executive Pharmaceutical Validation

Key Responsibilities
You will play a critical role in establishing and maintaining validation systems for a sterile pharmaceutical environment.

1. Facility & Utility Validation

Develop and execute validation protocols for HVAC systems (cleanroom ISO classification)

Validate water systems (PW, WFI), compressed gases (CDA, Nitrogen), and clean steam systems

Perform SIP qualification activities

2. Equipment Qualification

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

Execute IQ, OQ, and PQ protocols

Prepare traceability matrices and perform documentation review

3. Computer System Validation (CSV)

Validate GxP systems such as BMS and EMS

Conduct risk assessments and manage validation lifecycle documentation

4. Cross-Functional Coordination

Work closely with Engineering, Production, QC, QA, and Project teams

Participate in FAT and SAT activities for new equipment

Support technology transfer processes

Assist in deviation investigations and CAPA implementation

5. Compliance & Documentation

Ensure all validation and qualification documents are maintained in accordance 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 advantage

Experience

Minimum 5 years of experience in pharmaceutical validation

Experience in greenfield sterile plant setup is highly preferred

Exposure to regulatory audits

Experience in injectable or biologics manufacturing environments

Knowledge of Quality Risk Management (QRM)

Technical Skills & Knowledge
Strong expertise in aseptic processing and sterilization validation

Hands-on experience with HVAC qualification and cleanroom standards

Familiarity with Annex 1 (latest revision) requirements

Experience in aseptic process validation and media fills

Strong documentation and report writing skills

Risk-based validation approach

Strong analytical and problem-solving capabilities

Competencies
Strong communication and stakeholder management skills

Ability to work across cross-functional teams

Detail-oriented with strong compliance mindset

Proactive and eager to continuously learn and improve