Validation Engineer

Location Seremban, Malaysia
Discipline
Job reference 159103
Consultant email mahi.h@manpower.com.my

Validation Engineer, Commissioning & Qualification —Pharma

Location: Seremban, Negeri Sembilan

This position shall perform commissioning and qualification of Pharmaceutical equipment, including any or all of systems for Oral Solid Dosage, Chemical API (Synthesis & Purification), Fill/Finish. Equipment’s like RMG, CoMil, Table Coating Machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc.


Responsibilities

  • Develop risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.

  • Develop and execute Commissioning and validation of Pharma Process Equipment’s for


API, Fill/Finish and OSD.

  • Preparation of System Boundaries, SLIA, CLIA, QRA, RTM, Facility Risk Assessments

  • Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.

  • Investigate deviations, write investigation reports and create summary reports.

  • Promote cGMP and regulatory compliance into assigned projects.

  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

  • Hands on Experience with Pharma Process Equipments.

 

Qualifications & Other requirements

  • BS/MS in Engineering (Chemical, Pharma).

  • 4-10 years in validation, quality systems, operations, engineering or any combination thereof.

  • Experience in multiple GMP validation disciplines with advanced technical knowledge.

  • Validation experience using , traditional, risk based, Hybrid approach.

  • Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards.

  • Experience working with Documentum or Maximo a plus.

  • Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.

  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.

  • Strong verbal and written communication skills; excellent organizational and time utilization skills

  • Ability to work independently and within project teams.

  • Industry experience related to cGMP drug manufacturing, validation, and chemical process design

  • Strong computer knowledge including Microsoft Office products

  • Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel