Microbiology QC Testing

Microbiology QC Testing , Manufacturing Support - Dun Laoghaire, Dublin

Office/Project Location:Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  On Site

Pay: €25 - €35 per hour

Experience: 3+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance.

This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing.

The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team.

This role will support manufacturing operations, as such some extended hours, shift and weekend work may

be necessary as required.

Endotoxin testing of water, in-process and drug product release samples

Bioburden testing of water & in-process drug product samples

Sterility testing

Water sampling

Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.

Writing technical reports

Perform analytical testing as a main priority with efficiency and accuracy

With a high degree of technical flexibility, work across diverse areas within the lab

Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.

Report, evaluate, archive, trend and approve analytical data.

Troubleshoot, solve problems and communicate with stakeholders.

Initiate and/or implement changes in controlled documents.

Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

Write protocols and perform assay validation.

Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

Review and Approve lab results

May participate in lab investigations.

May provide technical guidance.

May train others.

May contribute to regulatory filings.

May represent the department/organization on various teams

May interact with outside resources

Requirements

Bachelors degree in a science discipline

Biopharmaceutical QC experience in a microbiology lab

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Experience working in endotoxin, bioburden or sterility testing

Proficient in GMP systems such as LIMS Labware & LMES

Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.

Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning

Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills

Take initiative to identify and drive improvements

Excellent verbal and written communication skills

Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)

Presentation skills

Escalate issues professionally and on a timely basis

Decision Making skills

Teamwork and Coaching others

Negotiation and Influence skills

Problem solving skills

Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope

Ensures compliance within regulatory environment

Develops solutions to technical problems of moderate complexity

Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues

Interprets generally defined practices and methods

Technically strong background in microbiology and aseptic manufacturing

Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage

Flexibility – the role often encounters changing priorities (also required to work weekend on call – Rota system)

Demonstrated ability to work independently and deliver right first time results

Works under minimal direction, Recognizes and escalates problems

Work is guided by objectives of the department or assignment

Follows procedures

Refers to technical standards, principles, theories and precedents as needed

May set project timeframes and priorities based on project objectives and ongoing assignments.

Package

Contract role - Hourly rate €25 - €35 per hour

Minimum 12 month contract

Location: Fully onsite, with hours from 08:00 to 17:00.

On-Call: You'll be on rotation every 8 weeks.

If a bioburner sample pops up, you'll need to step in and handle the testing.