The Senior Validation Engineer will be responsible for conducting key validation activities, including Commissioning and Qualification, Performance Qualification (PQ), Cleaning Validation (CV), Process Validation (PV), and Revalidation (RV).
Key Responsibilities:
Develop and oversee detailed project plans and timelines for validation execution.
Prepare validation documentation such as protocols, change controls, and summary reports.
Lead validation efforts for CD/PQ/CV/PV/RV activities.
Serve as project manager, ensuring timely implementation of new systems according to set timelines and budget forecasts.
Monitor progress, identify issues, and provide reports on any impact to timelines or complications encountered.
Contribute to investigations that could affect validation outcomes.
Coordinate the collection, testing, analysis, and reporting of samples in accordance with validation protocols.
Support change management for validated equipment, utilities, and facilities.
Assist in the creation and refinement of manufacturing documents as needed.
Qualifications / Requirements:
BS/MS in Chemical or Biochemical Engineering, or a related field, with a minimum of 8 years (BS) or 6 years (MS) of experience in drug product process R&D, Engineering, Manufacturing, or Technical Services.
Proven experience in the pharmaceutical/biotech industry.
Expertise in cleaning and sterilization validation, with a solid understanding of qualification requirements in a cGMP environment.
Strong project management capabilities.
Experience in authoring, reviewing, and executing validation protocols.
In-depth knowledge of cGMP regulations or equivalent standards.
Familiarity with equipment qualification related to formulation, filling, and packaging in a regulated setting.
Ability to collaborate effectively with internal teams, external partners, suppliers, and clients.
Operational excellence and industrial engineering expertise is a plus.