QC Lab Support Validation Engineer
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| Job Type | Contractor |
| Area | Westmeath |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2345 |
| Job Views | 218 |
- Description
- We are seeking applications for an experienced QC Lab Support Validation Engineer for our client, who are a leading biopharmaceutical company based in Athlone. The successful applicant will oversee the routine equipment maintenance and provide Equipment & Instrument Qualification Support to the QC Microbiological and Chemistry laboratories in Athlone to support the advancement of new QC technologies and facilitate new product introduction
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Manage routine laboratory equipment maintenance, qualification and periodic review
Schedule and oversee vendors responsible for lab equipment maintenance/calibration
Support troubleshooting of instrumentation/equipment issues in the lab
Act as lab systems administrator for all QC Laboratory Systems/equipment
Planning and conducting routine calibrations and maintenance of lab equipment where required
Support the introduction of new QC equipment requiring the planning, executing and documenting the qualification of new lab equipment in cGMP regulated environment.
Generate IQ/OQ & PQ equipment validation protocols and associated reports.
Ensuring high cGMP, GLP standards are maintained and adherence to schedules and targets to meet regulatory and business requirements.
Evaluate systems/equipment in accordance with cGMPs, Part 11 & other regulatory requirements Generation and resolution of protocol discrepancies and deviations as required.
Ensure all equipment related QC Procedures and other GMP documentation are implemented and continuously maintained in a compliant and inspection ready manner.
Proactively engage with stakeholders and routinely present project progress updates to senior QC management
What you need to apply:
Minimum of 7 years of laboratory experience in a cGMP laboratory and instrument validation experience is desirable
Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
In depth understanding of current regulatory requirements for cGMP laboratory equipment validation and calibration
Excellent technical competency in the field of instrumentation and equipment validation.Skilled in organisation, planning, priority setting and time management.
Works in a collaborative manner and is able to develop excellent working relationships with peers. Excellent report writing skills.
Takes a structured, analytical approach to problem solving.
