Engineer, Validation

Title: Engineer, Validation Description: Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve. At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 900 employees and 3 factories for the production of injectable medicines. Hikma, intends to recruit an Engineer, Validation (m/f) to integrate Validation Inspection Department, on-site work. Main Responsibilities: Operates instrumentation needed for particles identification and test sets preparation Prepares all test sets needed for inspectors and machines qualification for visible particulate matter and visual defects Ensure the good condition of all test sets under Insp. Validation responsibility, conduct regular checks Verifies results and coordinates inspectors’ qualification Manage the particles Library and keep it updated, reflecting new lines and new materials Operates instrumentation needed for calibration and testing of critical processes instruments and equipment Drafts and prepares documents on protocol execution/performs validation activities Performs data analysis and prepares written reports/summaries from validation studies, including Limit reports, from historical data, for rejection rates due to particles Support the management in critical documents, CAPA acting as CAPA owner Ensures execution and documentation of internal and external scheduled validation field activities Writes /reviews department applicable Standard Operating Procedures (SOPs) Liaises with external validation contractors, ensuring conformance of activities to procedures and processes Schedules in coordination with Other departments and Validation manager, equipment times, prepares test equipment and assures that testing is completed according to approved validation protocols Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed, for supporting audit preparation at site Profile: Bachelor's degree or equivalent in Technical / Science Demonstrated computer skills including Word, Excel and CAD English Intermediate Level Ability to work as part of a team Good analytical and organizational skills and should have the ability to think critically Demonstrates proactivity Availability to work between the morning shift (7:15 a.m. to 3:15 p.m.) and the afternoon shift (3:15 p.m. to 11:15 p.m.) We offer: Direct contract with Hikma Salary appropriate to the functions performed Life insurance Health insurance Annual Performance Bonus High career prospects If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day Location: Sintra, Sintra, PT Find similar jobs: