The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements.
Job Function:
Prepare and execute IQ / OQ / PQ protocols and write summary reports for production/packaging equipment, utilities (Temperature mapping study, Stability Chamber , HVAC, Air compressor, Boiler, Purified water system) and process area etc.,
Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP.
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.
Manufacturing / Production environment
Environmental related to manufacturing/production environments:
Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
Odors: Unpleasant smells.
Gases: Examples include carbon monoxide and ozone.
Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.
Education and Experience
Minimum of five (5) years in Pharmaceutical, preferably Oral Solid Dosage.
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 skill
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).