- update, and review Engineering Protocols (ENP) and Reports (ENR), Stability Protocols (STP) and Reports (STR), Quality Work Instructions (QWI), Quality Operating Procedures (QOP), Quality Forms (QF), Templates, equipment design and qualification documentation (e.g., URS), Change Controls, etc.
- AS lab equipment such as Instrons, JOHOs, Vortex, vibration machine, environmental chambers, etc.
- and execute Test Method Development (TMD), Test Method Validation (TMV), Test Method Transfer (TMT), Container Closure Integrity Testing (CCIT), Robustness/Reliability Testing, Stability Testing, Transportation/ASTM Testing, etc.
- the SHL Pharma Stability Program.
- report, analyze, and review test results against specifications per Good Documentation Practices (GDP).
- testing activities to support the AS Key Performance Indicators (KPI).
- root cause analysis and work as a member of a cross-functional team to conduct Out of Specification (OOS) investigations, Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc.
- cleaning as well as corrective and preventive maintenance of AS lab equipment.
- as the second line of support after Manufacturing Engineering (ME) to Quality Control (QC).
- training on test systems and test methods to ME, AS, and QC personnel.
- the design, qualification, and implementation of new AS and QC equipment, including design documentation (e.g., URS, RTM) and computerized system validation.
- opportunities for continuous improvement in AS and support the execution and implementation of LEAN projects.
- and execute early development studies (e.g., feasibility studies), as needed.
- as an SME for health authority and regulatory bodies audits and inspections.
- with all quality, safety, and work rules and regulations.
- other related duties as assigned.
- Degree required, preferably in Biomedical Engineering/Mechanical Engineering or another relevant branch of study
- years of experience within the medical device industry
- of industry practices and guidelines including those outlined by the FDA, ISO, and ASTM
- of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP)
- in Microsoft Office
- communication (written and verbal) and collaboration within cross-functional teams
- to work independently.
- required to use hands to finger, handle, or feel objects, tools, or controls.
- with hands and arms.
- standing, prolonged sitting.
- stooping, kneel or crouch.
- vision abilities required include close vision, and the ability to adjust focus.
- compensation package
- working environment with state-of-the-art facilities and technologies
- assignments in a fast-growing and innovative industry
- in a dynamic, international team of highly skilled professionals.
- opportunities for personal and professional development within a global organization
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Analytical Science Engineer - Deerfield Beach, United States - SHL Medical
Description
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
Execute Analytical Sciences (AS) project activities under the guidance of AS Senior Engineers/AS Principal Engineers and the AS Manager.
Main Responsibilities
Skills and Qualification
We Offer
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 via the Easy Apply button or directly to -.
For more information on SHL Medical, please visit:
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Please note: For this position, we do not consider applications from recruitment agencies.
