Validation Engineer – Equipment & Utilities Qualification

DGXPComplianceLab; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

DGXPComplianceLab is seeking a Validation Engineer to qualify manufacturing equipment, utilities and facilities to GMP expectations. The role includes qualifying HVAC, water systems and cleanrooms, coordinating FAT/SAT with vendors, and maintaining qualification status through periodic reviews.

The ideal candidate will have 4–9 years in equipment/utility qualification, strong knowledge of EU GMP Annex 15 and ISPE guides, experience with OSD or sterile facilities, and solid technical report

Qualifications

• 4–9 years in equipment/utility qualification.
• Knowledge of EU GMP Annex 15 and ISPE guides.
• Experience with OSD or sterile facilities.
• Technical report writing.

Responsibilities

• Qualify manufacturing equipment, utilities and facilities to GMP expectations.
• Qualify HVAC, water systems and cleanrooms.
• Coordinate FAT/SAT with vendors.
• Maintain qualification status and periodic reviews.

Skills

Equipment qualification

GMP/ISPE knowledge

OSD/sterile facilities

Technical report writing

Job description

Validation Engineer – Equipment & Utilities Qualification

Qualify manufacturing equipment, utilities and facilities to GMP expectations.

• Qualify HVAC, water systems and cleanrooms
• Coordinate FAT/SAT with vendors
• Maintain qualification status and periodic reviews

Required skills

• 4–9 years in equipment/utility qualification
• Knowledge of EU GMP Annex 15 and ISPE guides
• Experience with OSD or sterile facilities
• Technical report writing

Preferred skills

• Temperature mapping and HVAC testing experience