Senior Validation Engineer
Senior Validation Engineer
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.
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.
- Primary contact and lead SME for all Operations related validation activities at the site (production equipment, production 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
Skills and Qualification
- Degree in Engineering or equivalent education/experience
- A minimum of 5 years of relevant experience as a Validation Engineer in the medical device industry, preferably with plastic injection molding and/or automated assembly equipment experience
- 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 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
- Ability to perform multiple tasks and prioritize workload.
- Effective analytical, technical, and problem-solving skills.
- Willingness to work from/relocate to Charleston, South Carolina is required.
- Willingness to initially spend an extended period in our facility in Taiwan for induction/training is a plus
- Excellent intercultural and interdisciplinary communication skills
The physical demands described here are representative of those that must be met by and employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel objects; and reach with hands and arms. The employee must regularly lift and /or move up to 10 pounds.
- 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
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.Apply for this job