LSC have an exciting opportunity for QC Lab Support Validation Engineer to join our team with our Athlone based biotech client. You will be part of the QC team responsilble for the purchase, receipt and qualification of new lab testing equipment.
Your responsiblities will include:
o Evaluate systems/equipment in accordance with cGMPs, Part 11 & other regulatory requirements
o Establish working knowledge with regards to regulatory requirements for equipment qualifications and calibration
o Work closely with user groups to evaluate, develop, implement & maintain systems to improve process, streamline workflow and generally increase productivity in lab operations
o Planning, executing and documenting the qualification of anew lab equipment in cGMP regulated environment
o Developing and maintain an equipment qualification project plan as part of the commissioning of new laboratory facilities
o Writing IQ/OQ & PQ equipment validation protocols and associated reports.
o Planning and conducting routine cals. and qualification of lab equipment
o Generation and resolution of protocol discrepancies and deviations as required.
o Execution of validation activities and oversight of vendor activities
o Protocol and report writing for test method qualifciation
Your education and experience will include:
o Minimum of 2 years of laboratory experience in a cGMP laboratory and instrument validation experience is desirable
o Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
o In depth understanding of current regulatory requirements for cGMP laboratory equipment validation.
o Excellent technical competency in the field of instrumentation and equipment validation.
o Skilled in organisation, planning, priority setting and time management.
o Works in a collaborative manner and is able to develop excellent working relationships with peers.
o Takes a structured, analytical approach to problem solving.Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices (GAMP) to ensure site automation systems are cGMP compliant.
o Good interpersonal skills are required, as is the ability to communicate well, both verbally and written documents.
Please contact Kathy on 021 4777329 for full details of this role or apply directly through this advert.