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Summary
We are currently recruiting for a Microbiology analyst to be part of a new product
06 - Associate, Operations Quality 1
Req ID: 126866
Remote Position: No
Hiring Manager: Bobby Smith
Band: 06
Region: Europe
Country: Ireland
State/Province: Galway
City: Galway
General Overview
Functional Area: OPS - Operations
Career Stream: QUA - Quality
Role: Associate
SAP Short Name: ASS
Job Title: Quality Associate
Job Code: AST-OPS-QUA
Job Level: Band 06
Profile-Holding: Y
Direct/Indirect Indicator: Indirect
Summary
We are currently recruiting for a Microbiology analyst to be part of a new product
introduction in Galway. By Joining Celestica Galway (Ireland) as a Microbiologist Analyst
you will have the opportunity to work on delivering a fully automated high volume
manufacturing line from development stage to full scale production ramp producing world
class medical devices in a dynamic, fast moving environment.
A career at Celestica is only for those who want to do something extraordinary with a
meaningful purpose: imagine, develop and deliver a better future with our customers.
Celestica is a leader in high – reliability design, manufacturing and supply chain solutions
that bring global expertise to every stage of product development. Join us in Galway, Ireland,
to contribute to extraordinary advancements in the Med Tech sector.
See Job Description Below
Your next challenge will be…
To maintain high – quality standards in a dynamic laboratory environment.
Detailed Description
Your day to day activities will include the following…
Environmental monitoring of cleanrooms for viable air, viable surface and particulate
in line with ISO 14644 standards.
Monitoring of utilities including all grades of water, and where necessary, compressed
air.
Co-ordination of samples for bioburden and endotoxin testing.
Ordering consumables (media etc) and general stock for day-to-day running of
laboratory.
Applying cGLP to all laboratory activities including stock control.
Performing sampling for validations and re-qualifications as required. Review of
validation files for compliance.
Interpreting sampling and monitoring data, applies statistical and analysis techniques,
to determine control and trending.
Leading NC and CAPA generation and resolution within the Microbiology group and
across related business units.
Performing sterility release review, interpreting data and trends.
Identifying opportunity for stabilization of trends, statistical control of processes to
allow cost saving.
Mentoring and training team and cross functional groups as required (induction, GMP
etc)
Contributing to the development, maintenance and improvements of the policies and
procedures to align to best practices, benchmarking against industry leads and
regulatory requirements.
Coaching, mentoring and training other functions in area of sterility and monitoring.
What Do We Offer
Market-competitive total reward: flexible salary, fix and variable salary based on
goals
The opportunity to become a key member of the new product introduction team in the
Health Tech Quality function driven by innovation where creativity matters.
Training and development opportunities, with us the sky is the limit!
The opportunity to innovate, learn, mentor others and work toward your own vision of
career success
A global, collaborative culture with strong leadership imperatives to foster your
growth and professional opportunities
A sustainable culture where we provide opportunities for employees to give back to
the community.
Knowledge/Skills/Competencies
What do we expect from you?
Strong knowledge of quality tools, QSR, ISO/MDR standards, and processes.
Strong interactions, maintenance and support of sterility suppliers
Strong competency in troubleshooting, correction of NC and root cause analysis.
Effective communication, project management, and influencing skills.
Strong analytical and critical thinking skills.
Thorough working knowledge of sterilization processes, validation techniques, and
cleanroom monitoring/standards.
Experience in working independently in compliance risk situations.
Typical Experience
What are we looking for?
Bachelor’s degree of Microbiology or equivalent.
2+ years of Sterilization/Microbiology engineering experience preferred.
Openness to short-term travel assignments, especially in the early project stages.
Experience in the Medical Device industry or another highly regulated environment.
Familiarity with 6 Sigma quality methods is advantageous.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Manufacturing
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