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Staff Technology Program Manager
CDK Global, LLC
Austin, TX
We are seeking a strategic and highly technical Staff Technical Program Manager to lead complex, enterprise-wide initiatives that accelerate CDK's modernization efforts and Agentic AI…
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Manufacturing Engineer
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IT Manager
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Added 3 mins ago
Senior Project Manager
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Join our team as a Senior Project Manager where you will be responsible for the overall direction, completion, and financial outcome for several small to medium projects or one very large…
Added 4 mins ago
Director of Equipment
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Quarry Superintendent
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…supervision, leadership, and technical expertise in the mining process. S/he will ensure mining development and production activities are conducted in a safe and environmentally responsible…
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Engineering Unit Manager
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- $99,000 to $157,000 USD / year
Join our dynamic team as an Engineering Unit Manager at our facility located in Mount Vernon, Indiana. In this pivotal role, you will provide exceptional engineering services for our…
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Civil Project Engineer P.E.
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CIVIL ENGINEER PROJECT ENGINEER or PROJECT MANAGER SUMMARY: Plans, designs and directs, engineering projects such as streets, roads, residential and commercial developments, municipal…
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Manager of Customer Success, Activation
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Product Owner - ServiceNow Platform
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Procurement specialist
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Payroll / Accounts Payable Specialist
Illinois Tool Works
Hatfield, PA
…the world. Our high-tech products are used in laboratory and process applications in end markets such as: oil & gas, petrochemical, medical devices, waste water, life sciences, and…
Added 6 mins ago
Senior Solution Architect
Blitzy
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- Experience as an Engineering Manager, Technical Lead, or Solutions Architect
Added 6 mins ago
Process Tech - Plastic Injection Molding 3rd shift
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Runs the machine to accept the process. If the mold is run outside of the process, the Shift Lead/Manager must sign off on the change, and a written notification given to the process…
Added 7 mins ago
Director of Equipment
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Atlanta, GA · Medley, FL · Tampa, FL · Jacksonville, FL · Birmingham, AL · CHARLOTTE, NC
…Join one of the largest construction firms in the country (Engineering News-Record [ENR]: #1 in Power, #16 Top 50 Domestic Heavy Contractors, #13 Transportation…
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Graduate – Digital - Products & Projects - Houston
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Executive Director, Physical Facilities
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Added 7 mins ago
Maintenance Technician I
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Under the direction of the Process Engineering Manager, the Maintenance Technician I will be responsible for performing duties to repair and maintain machinery, equipment, building and…
Added 8 mins ago
Sr Manager Strategic Capacity Management
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Johnson & Johnson MedTech is recruiting for a Sr Manager Capacity Management located in Jacksonville, FL!
Added 9 mins ago
Product Manager
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Added 9 mins ago
PLANT MANAGER
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POSITION OBJECTIVE: The Plant Manager is responsible for the overall day-to-day operation, leadership and management direction to ensure safety, quality, financial, operational,…
Added 10 mins ago
Technical Account Manager - Water Treatment Chemicals
Veolia Environnement SA
Schenectady, NY
Join Veolia as an Account Manager in our Chemical Solutions and Monitoring (CSM) division and be at the forefront of innovation and sustainability!
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Technical Account Manager - Water Treatment Chemicals
Veolia Environnement SA
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Join Veolia as an Account Manager in our Chemical Solutions and Monitoring (CSM) division and be at the forefront of innovation and sustainability!
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Brewery Chemical Sales Area Manager
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Required: BS/BA degree in dairy, brewing, beverage, food or agricultural science, engineering, chemistry, biology or related field

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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