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Quality Engineer Microbiology - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 11/27/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:
    11/27/2018

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Job Function Summary:

The Quality Engineer Microbiology role has the responsibility for analyzing and/or performing cleanroom environmental testing following standard procedures and/or quality plans and managing on-site contract service laboratory personnel. The position is also responsible to manage and analyze biological product testing including product bioburden and bacterial endotoxin testing following standard procedures.  Management includes, but is not limited to, scheduling and management of on-site supplier visits, scheduling and management of test sample shipments to contract laboratories, purchase orders, test documentation, invoice review, cost reconciliation, and budget review. Responsibilities also include completing equipment qualifications (EQ) for cleanroom measurement equipment, nonconformance reviews, CAPAs, and performing special projects as assigned.

Job Functions

•     Investigation and corrective action determination for all microbiology related excursion events for both environmental and product testing.

•     Responsible for all Controlled Environment and Product Testing Nonconformance Reviews

Act as a representative of CE&S for cross functional projects and investigations.

•     Environmental monitoring and  Utility monitoring including compressed air and nitrogen system  – facilitating, collecting, reviewing, analyzing and/or reporting data

•     Support design changes, part qualifications, and non-routine manufacturing builds subject to sterilization.

•     Author product microbiology qualification protocols and reports for the evaluation of design changes.

•     Managing of the following testing categories, events and associated data:

•             Product bioburden testing

•             Product bacterial endotoxin testing

•             Sterility Testing

•             Environmental Monitoring and Critical Utility Testing

•             Biological Indicator Verification

•     Execute and/or review Trend Analyses of CE&S product, Controlled Environment and Utility Data.

•     Create CE&S Test Result Summaries for Management Review.

•     Creation and execution of equipment qualifications.

•     Creation and execution of controlled environment microbiological performance qualifications.

•     Selection and maintenance of controlled environment sampling locations

•     Maintenance of the contamination control cleaning program and its respective cleaning agents.

•     Selection and maintenance of microbiological product families and sub-groups

•     Responsible for managing contract service laboratory testing, communications, and on-site visits.

•     Responsible for training CE&S on-site contract service providers

•     Assigned CAPA Team Leader Role for microbiology and controlled environment associated CAPAs

•     Act as Microbiology SME interdepartmentally

•     Decides if the Controlled Environment and production needs to be shut down in the response to contamination events or adverse environmental or product testing trends

•     Provides guidance regarding the impact of building monitoring system alarms and approves alarm reports as necessary.

•     Performs special projects as required

Required Knowledge, Skills and Abilities:

  • Demonstrated ability to learn and understand procedure and protocol
  • Good computer skills including MS Office (Outlook/Word/Excel).
  • Working knowledge of GMP, FDA, and ISO standards is desirable.
  • Able to work in a controlled clean environment.
  • Self-motivated and able to take direction to perform all necessary duties.
  • Multitasking and employing effective prioritization

Minimum Requirements: 

  • A Bachelors’ Degree in Engineering, Biology, Microbiology, Chemistry, or a related science and five years’ experience in a medical device or pharmaceutical environment
  • Equivalent work experience shall be acceptable in place of education at the discretion of the Director, CE&S.  Work experience shall include a minimum of five years’ experience in a medical device or pharmaceutical environment.
  • Accurate – Ability to perform work accurately and thoroughly.
  • Communication (Oral/Written) – Ability to communicate effectively in oral and written form.
  • Problem Solving – Ability to find a solution or deal proactively with work related problems.
  • Interpersonal – Ability to develop and sustain positive relationships with internal as well as external
  • Duties are performed in a manufacturing environment.
  • Personal protective equipment may be required as dictated by work environment.

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.

 

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We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.