SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview
The Validation Engineer is responsible for validating all equipment and injection molding tool used in injection molding related process, including resin incoming inspection equipment, measurement equipment, etc. 

Main Responsibilities

• Responsible for following all applicable SOPs and WIs at all the times.
• Responsible for following the principle of GMP to the best of their ability at all times.
• A Validation Engineer II is with basic ability to execute job tasks below independently.
• Evaluate the necessity of validation activity or design validation scale according to the validation policy in SHL.
• Generate validation plan and reports.
• Establish validation agenda and arrange validation runs, testing, and metrology.
• Implement tool or equipment/process validation activities and collect the related test result.
  • Participant in deviation handling led by investigation leader. Together coming out action plan and proceed further validation activities based on the plan.
  • Participant in and provide audit materials of validation execution level.Assign above job tasks by staffing qualification / personal ability / organization needs.
• Assist injection molding process development related activities.
• Carry out other duties as assigned.

Skills and Qualification

• 3+ years of experience withing engineering/manufacturing
• Bachelor's degree in Mechanical Engineering, Materials Engineering, Medical Device Engineering with mechanical emphasis, Electrical Engineering, automotive engineering or related field.
• Strong data analysis skills utilizing software such as Minitab.
• Skilled in the use of Microsoft Office Suite
• Excellent verbal and written communication skills in English
• Working knowledge of GMP, ISO, and FDA rules and regulatory requirements (etc. ISO 13485, ISO 14971, ISO 11608 , 21 CFR Part 11, 21 CFR 820 and FDA GMPs)
• Experience in developing and executing IQ, OQ and PQ documentation for GMP equipment
• Common risk management techniques (etc. FMEA, Fault-tree analysis)
• Experienced with equivalent test, process engineering, failure investigations, root cause analysis, measurement system analysis and automated assembly equipment is preferred

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitUS@shl-group.com.

For more information on SHL Medical, please visit: shl-medical.com