Microbiologist Analyst

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.