Responsibilities:

• Develop, review and/or approve validation lifecycle documents and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. 

• Take lead and review project design documents (P&IDs, PFDs, URS etc.) 

• Define user requirements and create SOPs or documentation related to the validation activities 

• Manage qualification execution and lead validation deviation investigation encountered in qualification.

• Create and review validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier

• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities

• Participate in site Validation Maintenance Program.

• Write execution related deviations and change requests

• Support change implementation on site.

• Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix and/or Automation System Life cycle documentation as needed

• Perform validation documentation and/ or support validation documentation in accordance to the division procedures

• Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager

• Ensure validation execution meets compliance, validation standards and cGMP requirements 

• Any other task as assigned by Supervisor/Manager

About You:

• Diploma/Degree in Engineering or Science Disciplines with 3 to 5 years experience in Pharmaceutical Industry 

• Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV)

• In-depth knowledge on cGMP, GDP and ASTM E2500

• Proactive and self-motivated

• Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations)  

• Effective Project Management, leadership, communication and interpersonal skills