Validation Engineer

Job Title : Validation Engineer - Pharmaceutical

Job Summary :

The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements.

Minimum Experience : Minimum of four years in Pharmaceutical, preferably Oral Solid Dosage.

Area of Responsibility :

• Prepare and execute URS, IQ / OQ / PQ protocols and write summary reports for production and packaging equipment, utilities equipment like HVAC, Air compressor, Boiler, Purified water system, area qualification, and temperature mapping study of warehouse and storage area.
• Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP.
• Coordinate commissioning activities for engineering projects of new area and equipment.
• Review and execute PPV (Periodical Performance Verification of equipment).
• Prepare and train for the Set up / Operational / Cleaning / Maintenance SOPs.
• Identify, investigate and troubleshoot deviations for multiple concurrent projects.
• Preparation of Personnel flow, Incoming and Finished material flow, as well as Waste flow in the facility.
• Assist in preparation of internal audit, FDA, DEA and other agency audit responses.
• Prepare, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Write investigations and complete them in a timely manner.
• Create and close all change controls, CAPA and investigations in a timely manner.
• Create SOPs for facilities and utilities.
• Monitor work order status and ensure completion and filing, follow up with maintenance mechanics to close open work orders in a timely manner.

Education and Qualifications :

• Bachelor’s Degree in Engineering or Science related field.
• Technical and analytical ability to analyze engineered systems and equipment operation as well as quality and compliance systems that supports production operations as well as research and development.
• Good understanding of cGMPs and good documentation practices in order to prepare system life cycle technical documents such as URS, FRS, VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPs, Validation (PQ, DS, CV, PV), FMEA and Validation Master Plan.
• Technical knowledge to write, prepare and execute the Change Controls, Investigations, SOPs, protocols, final summary reports and validation documents.
• Demonstrated excellent communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• A team building champion driving innovative cross functional synergies.
• Excellent project management and problem solving skills.

Language Requirement : The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).