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Validation Engineer
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PSC Biotech Rockville, United StatesRockville, United States · | Posted on 05/01/2024 · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements ...
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Validation Engineer
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Validation Engineer III
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Manager, Validation Engineering
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Senior Validation Engineer
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Manager, Validation Engineering
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Specialist Manufacturing Engineering Validation - Germantown, 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 DescriptionProvide vital technical support to QIAGEN's validation activities concerning filling, capping, labeling, and 96 well plate manufacturing equipment.
Duties include:
1. Generate, review, and execute validation-related technical and engineering documentation;2.
Guide and mentor technical and engineering teams regarding the purpose of equipment installation as well as operation, performance, and process validation;3.
Provide technical assistance to operations personnel concerning engineering changes and qualification activities;4. Conduct engineering and process capability studies in support of validation activities;5. Summarize and analyze qualification and study data in spreadsheets and reports;6. Study product characteristics or customer requirements to determine validation objectives and standards;7.Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of production problems;8.
Create, populate, and maintain databases for tracking validation activities, test results, and validated systems;9. Coordinate the implementation and scheduling of validation testing with affected departments and personnel;10. Prepare, maintain, and review validation and compliance documentation, such as engineering change notices, schematics, and protocols;11. Design validation study features, such as sampling, testing, and analytical methodologies;12. Recommend resolution of identified deviations from established product and process standards#LI-DNI Position RequirementsMinimum Requirements:
A Master's degree or foreign equivalent in Mechanical Engineering, Manufacturing Engineering, or a related discipline plus 3 years of post-baccalaureate experience in a validation engineering-related occupation.
In the alternative, the employer will accept a Bachelor's degree or foreign equivalent in Mechanical Engineering, Manufacturing Engineering, or a related discipline followed by 5 years of post-baccalaureate experience in a validation engineering-related occupation.
Experience must include the following, which may have been gained concurrently:1) 3 years of validation experience in a regulated manufacturing environment, including cGMP 21 CFR 820 and ISO 13485;2) 3 years of experience with laboratory and manufacturing equipment and processes;3) 3 years of experience using temperature mapping validation equipment and software;4) 3 years of experience using data logging equipment;5) 3 years of experience using analytical software, including Minitab and Distribution Analyzer;6) 3 years of experience using asset management software, including Blue Mountain Regulatory Asset Manager;7) 3 years of experience using document management software, including Master Control;8) 3 years of experience using compliance software, including TrackWise;9) 3 years of experience using project management software, including Microsoft ProjectPersonal RequirementsJob site:
19300 Germantown Road, Germantown, MD Full-time.
JOB OPPORTUNITY QUALIFIES FOR EMPLOYEE INCENTIVE REFERRAL PROGRAM.
To learn more & to apply online, visit our website at:
& reference Job ID: US/CA01626 What we offerAt the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We 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.
#LI-DNI
