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Added 5 mins ago
ERS-NETA Electrical Testing Technician - Atlanta, GA
Vertiv
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Write complete, detailed reports promptly at end of project using a computer, and accurately process job billing.
Added 7 mins ago
Identity Governance and Administration (IGA) Engineer
ITC Digital Solutions
San Antonio, TX
ITC Digital Solutions is seeking a talented Identity Governance and Administration (IGA) Engineer to design, deploy, configure, and maintain enterprise-wide identity governance solutions…
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Project Engineer
Baker Construction
Dallas, TX
The Project Engineer supports field activities and spends a majority of time working with the Project Manager supporting project administration on multiple small projects, or one medium to…
Added 9 mins ago
Marine Engineer II
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San Diego, CA
As a Military Marine Systems Engineer, you will be providing technical support to U.S. Navy Surface Ship Fleet. The work directly supports fleet readiness, sailor safety, and material…
Added 9 mins ago
Product Manager
Vestwell
NY · Austin, TX · King of Prussia, PA · Scottsdale, AZ
…execute our product vision, improving the requirement-intake process, and implementing new processes on a quarterly basis. Vestwell is a continuously evolving data engine at its…
Added 10 mins ago
Full Stack Engineer, Applied AI
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San Francisco, CA · Sunnyvale, CA
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Added 11 mins ago
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Tool Development and Integration Engineer
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During your interview process, our team will provide details of our industry-leading benefits.
Added 12 mins ago
Engineer I, Controlled Environments
Getinge
Merrimack, NH
A Quality Engineer I, Controlled Environments, is responsible to provide engineering and technical support in the areas of Cleanroom Environmental Monitoring, Contamination Controls, and…
Added 13 mins ago
Maintenance Engineer $21.50
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Added 16 mins ago
Software Engineer I
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Plymouth, MA
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Added 20 mins ago
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Program Manager – DOE National Laboratory Capital Building Programs
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New York, NY
- $250,000 to $300,000 USD / year
Leading multidisciplinary technical teams across structural, mechanical, electrical, process, instrumentation and controls, and nuclear engineering disciplines
Added 20 mins ago
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Program Manager – DOE National Laboratory Capital Building Programs
AECOM
Boston, MA
- $250,000 to $300,000 USD / year
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Added 20 mins ago
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Program Manager – DOE National Laboratory Capital Building Programs
AECOM
Bloomfield, NJ
- $250,000 to $300,000 USD / year
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Added 23 mins ago
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Enterprise Solution Engineer - East
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Boston, MA · NY
- $160,000 to $180,000 USD / year
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Added 23 mins ago
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Digital Customer Success Manager
Sigma Computing
San Francisco, CA · NY
- $100,000 to $118,000 USD / year
Familiarity with data analytics and business intelligence concepts; you don't need to be a data engineer, but you should be comfortable talking to customers about their data workflows
Added 24 mins ago
Machine Learning Engineer 4 - Manager IC
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…emerging technologies to join our team. As a Machine Learning Engineer, you’ll have the opportunity to be on the forefront of driving major AI transformations and scaling production models…
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Full-stack Engineer 4 (Python, AWS)
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Added 24 mins ago
Senior Manager, Full-stack Engineer
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Added 26 mins ago
Senior Design Engineer - Mechanical Systems (Onsite)
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Pratt & Whitney is seeking an experienced Senior Design Engineer to join its Mechanical Systems design team within the Mechanical Systems, Externals & Nacelles (MSEN) organization. This…
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Added 26 mins ago
Senior AWS Cloud Engineer
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Added 26 mins ago
Software Development Engineer II, Amazon Prime Video
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We are looking for smart, motivated Software Development Engineer who can help in building platform for delivering live video events to our customer. If you have experience building…
Added 26 mins ago
Software Development Engineer II, FleetWatch Team
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Added 26 mins ago
System Development Engineer - AWS Cloudfront, AWS Cloudfront, Platform Services
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The System Development Engineer will design, build, secure, implement, code, automate, deploy, and root-cause complex system issues accross many different types of Linux bare metal servers.…

Getinge

Engineer I, Controlled Environments

Merrimack, NH, United States

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Job details

Apply by: Jan 2, 2027
Posting language: English
Posted: Nov 5, 2026

Original job description

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

A Quality Engineer I, Controlled Environments, is responsible to provide engineering and technical support in the areas of Cleanroom Environmental Monitoring, Contamination Controls, and Microbiological Testing. This includes development, revision, organization, administration, and compliance of the company’s routine Controlled Environment efficacy programs including Systems Qualification, Environmental Monitoring, and Biological Product Testing. A Quality Engineer, Controlled Environments, shall also perform tasks, as assigned, to support change control, CAPA activities, and other compliance activities related to the Controlled Environment and Contamination Control Programs.

Job Responsibilities and Essential Duties

Development, qualification, maintenance, and nonconformance analysis of a routine testing program for maintenance of a manufacturing environment suitable for the manufacture of medical devices. The program includes, but is not limited to, the following tests:
Air pressure differential measurement
Temperature and %RH measurement (where applicable)
Air Particulate Testing
Microbiological tests of system and testing waters
Biological Air Testing
Bioburden analysis (surface)
Compressed Air and Nitrogen Testing.

Microbiological Testing as part of the sterilization assurance and contamination control program also include the following:

Bacterial Endotoxin analysis of finished goods and in in-process components.
Bioburden analysis (finished goods)
Oversee and/or perform sampling for aforementioned test types as required.
Oversee, perform and/or review controlled environment and microbiological test result data entry.
Maintenance of contamination control, environmental monitoring, and bacterial endotoxin risk assessments.
Ensure continued conformance to existing standards (e.g. ISO 14644 series, ISO 11737-1, and ANSI/AAMI ST72), perform gap analysis for new/revised standards/guidance documents, and maintain compliance by implementing changes to conform (where applicable) to conform to new/revised industry standards.
Representing CE&S for Operations projects working towards optimizing the manufacturing workflow including equipment and work stream relocations.
Representing CE&S in cross functional project teams working towards introducing new products lines or expanding existing lines.
Development of Controlled Environment IQ/OQ/PQ protocols and reports to support facility and operation changes.
Maintenance of Controlled Environment Requalification Program, including generation of protocols/reports.
Generation and ownership of Controlled Environment, Contamination Control and Microbiological Testing CAPA Requests and CAPAs
Representing CE&S in cross function CAPAs where necessary.
Performance and/or supervision of additional departmental analysis, or tasks, including, but not limited to:
Writing, implementing, revising, and, or approving Standard Procedures (SPs), protocols, and reports relating to Controlled Environments.
Authoring, ensuring execution of and approving microbiological test method validations.
Generating Controlled Environment & Microbiological related content and controls within equipment relocation plans, part qualification, supplier change assessments, and design change quality plans.
Nonconformance technical support for controlled environment and product testing excursion events including root cause analysis and investigation.
Development, maintenance, and execution of Environmental and Product Microbiological Testing Trend Analysis Programs
Additional projects as assigned by Departmental Management.
Assists in special projects as needed.
Contributes to team effort by accomplishing related duties as requested.

Minimum Requirements

A Bachelors’ Degree in Engineering, Biology, Microbiology, Chemistry, or a related science and two years’ experience in a medical device or pharmaceutical environment.
Equivalent work experience shall be acceptable in place of education at the discretion of the Manager, CE&S.

Required Knowledge, Skills and Abilities

Highly organized with strong negotiation and communication skills.
Detail oriented with ability to self review
Familiarity with ISO Standards for Controlled Environments and Microbiological Testing
Ability to create and revise technical documentation as well as author position pieces with minimal guidance

Supervision/Management Of Others:

Internal and External Contacts/Relationships

Various

Quality Requirements

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions.
Duties are performed in an office environment.
Duties are performed in a manufacturing/clean room environment.
Personal protective equipment may be required as dictated by work environment.
Some duties may be performed remotely.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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