Commissioning, Qualification & Validation Engineer

Responsibilities

· Execute full-lifecycle qualification (DQ, IQ,OQ, PQ) for a wide range of analytical laboratory instruments, including but not limited to: HPLC/UPLC, GC, Mass Spectrometers, UV-Vis Spectrophotometers, FTIR, Particle Size Analyzers, Dissolution Testers, and Osmometers.

· Draft and execute validation protocols, risk assessments (FMEA), user requirement specifications (URS), functional specifications (FS), and qualification summary reports.

· Manage vendor qualification activities, review third-party execution documentation, and ensure vendor protocols align with site quality standards.

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

· Support qualification efforts for bioprocess development manufacturing equipment. such as bioreactors/fermenters, chromatography systems (e.g., AKTA platforms), tangible flow filtration (TFF)systems, automated cell counters, deep freezers, and incubators. 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.

· Preferably Hands on Experience with BiopharmaProcess Equipment.

Qualifications& Other requirements

· BE/B.Tech/Diploma in Biotechnology, Mechanical Engineering, Chemical Engineering.

· 5-15 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 and other in.

· Experience working with Documentum or Maximo, track wise a plus.

· 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.

Only shortlisted candidates will be notified

EnviroDynamics Solutions Pte Ltd I EA License No.: 12C6285

Ng Chin Shen I Reg. No: R25127347

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