Sr. Validation Engineer
Location: Charleston, South Carolina, US
Reporting to: Head of Manufacturing Engineering
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.
Job Overview
This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. Together with the rest of your team, you will drive and support validation activities of equipment and processes at our new state-of-the-art manufacturing facility.
Main Responsibilities
- Primary contact and lead SME for all Operations-related validation activities at the site (production equipment, production processes, auxiliary/supporting equipment & processes)
- Supporting Process/Equipment engineers and production with performing any required validations
- Developing and executing engineering and validation strategies, plans, and protocols for assigned regulatory compliance, change control, and design control projects, including Operations continuous improvements and technical transfers
- Participate as a critical team member on project teams to start up new facilities, equipment, or processes
- Writing and processing validation related documents through company systems
- Providing support for internal and external audits and Quality System investigations
- Creating and revising SOPs supporting Validation Program functions and activities requirements for new products, processes and equipment
- Plan and support execution of process, and/or equipment validation protocols (IQ/OQ/PQ) as necessary
- Remaining up-to-date and ensuring compliance with current industry trends as well as Quality Systems, ISO13485, cGMP and other relevant regulatory protocols
- Performs other related duties as assigned.
Skills and Qualification
- Bachelor’s degree in Engineering or equivalent education/experience required
- Minimum of 2 years of relevant experience as a Validation Engineer in the medical device industry, preferably with plastic injection molding and/or automated assembly equipment experience required
- Demonstrated knowledge of regulations and standards that apply to the medical device industry (cGMP, ISO13485, CFR 820, etc.)
- Understanding of the application of quality systems to the medical device industry
- Statistical analysis knowledge, including an understanding of how to execute and interpret Design of Experiments (DOE).
- Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies. Six Sigma certification is a plus
- Ability to perform multiple tasks and prioritize workload.
- Effective analytical, technical, and problem-solving skills.
- Excellent intercultural and interdisciplinary communication skills
- Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost
- Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done
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.
Please note: For this position, we do not consider applications from recruitment agencies.