Criterii de selecție:
- Peste 3 ani experiență în Audit / Consultanta, Auto / Echipamente, Controlul calitatii, Farmacie, Ingineri
Description: Validation Engineer will be responsible for validating/qualifying the equipments/systems used in the pharmaceuticals/food industries.You will help to demonstrate systems are running according to necessary specifications and operate with in regulations to ensure data integrity and the production of quality products. The Validation Engineeris primarily responsible for executing multiple projects, on both a large and small scale by performing the following: Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
– BS/BA degree in Engineering, Chemistry, Pharmacy or related science and a minimum of 2 years related experience or equivalent combination of education and experience.;
– minim 3 years pharmaceutical industry experience preferred
– Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
– Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
– Ability to work both independently and in partner ship withothers; provenability to use initiative and drive to achieve results;
– Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocolsacceptancecriteria;
– Willingness to travel. Travel can be for shorter periods of time or longer assignments (e.g. assessments, tests at customer site, as required)
– To performthis job successfully, an individual should have an advanced knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects);Advanced English competencies, both written and spoken;
– The position requires knowledge of cGMP and associated industry and regulatory guidance documents.
– Equipment Qualification – development of validation protocols, performs testing and writes validation reports for various equipment.
– Coordinates and communicate salltesting with affected functional groups and evaluates test results.
– Executes process validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
– Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
– Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
– Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
PHARMATOR is a engineering company providing solutions and services for customers in pharmaceuticals/ food industries.