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.
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Job OverviewA 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/RelationshipsQuality 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.
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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.
