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Laboratory Engineer - 2406195736W

Description

With an eye for better vision

Johnson & Johnson Vision develops and manufactures optical products and solutions that make a difference to human vision worldwide. We offer market-leading technology for laser surgery, equipment for cataract surgery and intraocular lenses.

In Uppsala, we manufacture Healon, a market-leading product used to stabilize the eye in connection with eye surgery. Upon its launch in 1980, Healon paved the way for safe and quick eye surgery, whereby a patient’s cataracts can be replaced with new lenses in just a few minutes.

Within J&J Vision – a part of the Johnson & Johnson MedTec business area - we are 8,400 employees, of which approximately 150 workers in our operations in Uppsala. Read more at www.jjvision.com

We’re recruiting for a Laboratory Engineer to be located in Uppsala, Sweden

Job position summary

Responsible for conducting technical quality assurance inspections and using results to improve production processes and standards.

Performs complex tests and analyses to assure that products comply with established specifications. Carries out calculations and prepares documentation that shows the results of tests performed. Completes record of inspection results, acceptance, rejection and disposition.

Enters data into logbooks or computer databases. Compiles data and prepares reports on findings. Conducts scheduled calibration and maintenance on test equipment.

Establishes maintenance and calibration schedule for test equipment based on manufacturers recommendations and maintains equipment records.

Coordinates specialized product/customer quality testing. Prepares custom reports on results.

Recommends and implements revisions, corrections and changes to test equipment, procedures and methods. Troubleshoots defective products returned by customers to determine root causes of failure.

Compiles data to identify trends and proposes corrective action. Initiates and coordinates discussions with quality, engineering, and other relevant departments to develop corrective actions for reoccurring problems.

Duties & Responsibilities:

• Microbiological and endotoxin testing of water systems

• Perform Microbiological and endotoxin testing on samples from raw materials, in-process samples, release, and stability

• Book in and control of samples

• Work with the Team Leader and Senior Microbiologist to organize work

• Perform support activities required for the function of the laboratory, including sterile and aseptic testing

• Support activities for people responsible to perform deviation investigations NC, CAPA, CC

• Writing and updating SOPs

• Responsible for use and validation of disinfectants

• Perform Hygiene Design inspections

• Reception, incubation, reading, and results reporting on samples from EM

• Conduct environmental monitoring sampling in laboratory and/or production areas

• Sterile checks. Perform survey for the sterile room such as the insertion of samples and consumables

• Responsible for ensuring that hygiene in the sterile room is ensured and maintained. Clean and clean up premises and equipment in the sterile room and perform environmental checks thereof. Conduct any additional tests

• Control of the department's equipment (cleaning, maintenance, calibration, qualification, and re-qualification)

• Establish and currently maintain the department's methods and routines-this based on scientific methodology and with support in applicable pharmacopoeia and QMS/GMP documents

• Review and approve analysis data and manage analysis data in SAP. Review and approve autoclave curves

• Preparation of self -made substrate within QCM

• Constantly improving and coming up with new solutions to facilitate work in the entire UQM department and in collaboration with production (sample management, etc.

• Experience with computerized systems for analytical tests, mainly endotoxins

Qualifications

• Academic college education (Biomedicinsk Analytiker, BMA) with an analytical orientation e.g., microbiology - or equivalent working -life experience

• Work experience from quality work in quality certified laboratory or manufacturing industry is a merit

• Experience and understanding of sterilization and sterilization processes and techniques are merit

• GMP/ ISO knowledge and experience of analyzes according to pharmacopoeias

• Good IT Knowledge

• Good knowledge of both Swedish (local language) and English in both speech and writing

• Cooperative, Meticulous, Cope with stress, Goal -oriented, Structured, Analytical, Creative, Easy to cooperate and communicate in speech and writing, Independent, Initiative ability, Integrity, Effective working methods, Ability for planning and prioritizing the department's goals and one's own work, Ability to cross -functional cooperation between departments - and have a holistic view

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

Primary Location Europe/Middle East/Africa-Sweden-Uppsala-Uppsala

Organization AMO Uppsala AB (8507)

Job Function Quality Control

Req ID: 2406195736W