Executive I / Executive II - Equipment Qualification, MS&T

Job Description

Title: Executive I / Executive II - Equipment Qualification, MS&T

Company Name: DBL Pharmaceuticals Ltd.

Vacancy: --

Age: At least 18 years

Job Location: Gazipur

Salary: Negotiable

Experience:

• 1 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Masters in Engineering (MEngg) in Pharmaceutical Technology

• 1 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Age At least 18 years

• Experience in MS&T, R&D, and/or Qualification & Validation within a reputed pharmaceutical company.

• Hands-on experience in equipment, facility, and utility qualification activities.

• Solid understanding of cGMP, Data Integrity, regulatory requirements, and qualification/validation practices.

• Working knowledge of ERP systems, with hands-on experience in SAP preferred.

• Proficient in MS Office and internet applications.

• Ability to work independently, manage multiple priorities, and perform effectively under pressure.

• Prepare and review User Requirement Specifications (URS) for facilities, utilities, systems, and equipment in compliance with cGMP, regulatory, and quality requirements.

• Plan and execute qualification activities for facilities, HVAC, cleanrooms, utilities (Purified Water, Compressed Air, Nitrogen, Steam), process equipment, and laboratory instruments as per the Validation Master Plan (VMP).

• Develop and implement IQ, OQ, and PQ protocols, reports, and supporting documentation to ensure compliance and audit readiness.

• Conduct risk and impact assessments to define qualification scope for new, modified, and existing systems.

• Perform periodic requalification and performance verification to maintain validated system status.

• Coordinate with Engineering, Production, QA, QC, R&D, and Maintenance for effective qualification planning and execution.

• Ensure data integrity and maintain complete qualification records throughout the validation lifecycle.

• Support deviation investigations, Change Control, and CAPA related to qualified systems.

• Drive continuous improvement of qualification and validation practices in line with current regulatory requirements and industry best practices.