Specialist – Engineering (Documentation & Validation Execution)

Pharmagend Global Medical Services Pte Ltd; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Pharmagend Global Medical Services Pte Ltd seeks an experienced Qualification and Validation Specialist to lead planning, execution, and oversight of qualification activities for equipment, utilities and facilities.

You will coordinate with cross-functional teams, manage change controls, write SOPs, and ensure activities stay in a validated state per regulatory guidelines. A degree in a scientific discipline and 5–7 years in pharma manufacturing are preferred.

Qualifications

• Degree in a scientific discipline.
• 5–7 years' relevant experience in pharmaceutical manufacturing.
• Knowledge of qualification/validation principles and their practical application.
• Proficient with Microsoft Word, Excel, Access, PowerPoint, and Explorer.
• Familiarity with regulatory/compliance environment.
• Ability to interact and lead effectively in a team-based environment.
• Experience in a regulated industry preferred.

Responsibilities

• Prepare and review qualification documents (URS, DQ, IQ, OQ, PQ).
• Execute qualification and validation activities across processes and facilities.
• Prepare and review process and cleaning validation protocols and reports.
• Coordinate with cross-functional teams and external service providers.
• Review change controls and perform risk assessments to determine criticality.
• Write, review, and revise validation SOPs complying with guidelines.
• QA oversight during the validation process.
• Manage incidents and deviations related to validation/qualification.
• Perform compliance reviews of deviations, investigations, and CAPAs.
• Suggest improvements to Validation Master Plan and validation strategies.

Skills

Team leadership

Regulatory compliance

Quality systems

Problem solving

Education

Degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

PowerPoint

Explorer

Job description

About the role

This role involves preparation and review of qualification documents including User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities and facility in compliance with regulatory guidelines. You will execute qualification and validation activities across process, cleaning, computer systems, equipment, utilities, and facilities, while coordinating with cross-functional teams and external service providers to maintain equipment, systems, and processes in validated state.

Key responsibilities

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines

• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility

• Preparation and review of process and cleaning validation protocols and reports

• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state

• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes

• Write, review, and revise validation SOPs in compliance with regulatory guidelines

• QA oversight and/or review during the validation process

• Manage incidents and deviations related to validation & qualification

• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation

• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies

About you

• Degree in a scientific discipline or equivalent

• A minimum of 5-7 years' relevant experience in pharmaceutical manufacturing environment

• Knowledge and experience of qualification/validation principles and their practical application

• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer

• Familiarity with regulatory/compliance environment

• Ability to interact and lead effectively in a team-based environment

• Experience in a regulated industry preferred