- Collaborate with Senior Engineers to understand equipment requirements and develop validation/maintenance plans and test protocols
- Execute validation tests or equipment maintenance tasks according to established procedures and protocols to satisfy QIAGEN master validation/maintenance plan, cGMP and ISO requirements
- Contribute to the creation and review of engineering drawings, specifications, and documentation
- Participate in design reviews and provide input on design improvements and optimizations
- Contribute to the development of new products and processes
- Support the creation and maintenance of validation/maintenance documentation including test reports, traceability matrices, and compliance documents
- Create and update SOPs for the equipment operation and maintenance
- Assist in troubleshooting technical issues and providing timely resolution
- Maintain accurate records and documentation related to engineering tests and activities
- Responsible for managing vendor on site qualification services
- Perform all other related duties as assignedPosition Requirements
- Previous experience or coursework in validation, testing, quality assurance, or a related field is preferred
- Familiarity with validation principles, methodologies, and tools
- Familiarity with regulatory requirement and standards (cGMP, ISO) is a plus
- Good logics to understand general production process
- Good organizational ability
- Strong analytical and problem solving skillsPersonal Requirements
- To perform this job successfully, an individual should have working knowledge of Microsoft Excel, Word, and other office software.
- Physically capable to perform the essential functions of this job.
- Good oral and written communication skills in English language is required.
- Team player What we offerAt the heart of QIAGEN are our people who drive our success.
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Mechanical Engineer - Frederick, United States - QIAGEN
Description
OverviewAt the heart of QIAGEN's business is a vision to make improvements in life possible.We are on an exciting mission to make a real difference in science and healthcare.
We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world.Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.Position DescriptionQIAGEN is adding an Mechanical Engineer to support qualifications/re-qualifications of manufacturing equipment and automation process development at Operation site in Frederick, Maryland.
The Mechanical Engineer will work closely with senior engineers and cross-functional teams to contribute to projects and initiatives aimed at delivering high-quality products and solutions.
KEY RESPOSNSIBILITIESWe drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.
QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs.
Candidates who require accommodation should contact .This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.