Validation Engineer

LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.

LTS´ commercial offering encompasses more than 20 marketed products.

LTS operates today from 5 sites: Netanya, Israel, Andernach, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA, and Shanghai, China.

We are looking for an excellent Validation Engineer to join our team in Israel. The position is hybrid - 4 days a week from the office, and 1 day from home.

Job Description:

As a Validation Engineer, your primary responsibility is to ensure the compliance, reliability, and functionality of medical devices throughout the product lifecycle, focusing on the production process. You will play a crucial role in developing and executing process validation protocols, conducting testing activities, and collaborating with cross-functional teams to guarantee the quality and safety of medical devices in accordance with regulatory standards.

• Design validation process for manufacturing jigs and tools – from manual jigs to fully automated manufacturing system.
• Compose protocols, execute procedures and write detailed reports for various validation activities – IQ\OQ\PQ
• Design, write, perform and document test method and software validation for testing devices and software.
• Establish new manufacturing process via NPI workstreams.
• Participate in departmental tasks of manufacturing engineering processes under medical devices standards – products and process maintaining, problem solving, design reviews, and critical/root cause analysis.
• Work closely with R&D, Quality Assurance, Regulatory Affairs, and other departments to lead new products process validations.

Job Requirements:

Education:

• B.SC. in Biomedical or Mechanical Engineering

Job skills:

• Experience of 3 years in medical device industry, preferably in clean room environment
• Previous experience in manufacturing process validation or a related field
• Knowledge in transfer from design to production
• Detail-oriented with a commitment to producing high-quality documentation processes.
• Proven analytical, problem-solving, and troubleshooting skills
• Testing of HW, SW, and mechanical sub-systems – an advantage
• Experience with using statistical methods for production reliability - an advantage

Computer skills:

• Full control of all MS Office applications

Language skills:

• Fluent English – written and spoken.

Personality:

• A “driver” personality, team player, meticulous, analytical mind, creative, expressive, excellent organizational skills