QC Lab Equipment
PE Global are currently recruiting for a QC Lab Support Engineer for a client site - Resource required to support the QC team in the purchase, receipt and qualification of new testing equipment to support Biologics testing. Resource will also support the team in the drafting of test method protocols and general lab support activities. Principal Responsibilities Evaluate systems/equipment in accordance with cGMPs, Part 11 & other regulatory requirements. Establish working knowledge with regards to regulatory requirements for equipment qualifications and calibration. Work closely with user groups to evaluate, develop, implement & maintain systems to improve process, streamline workflow and generally increase productivity in lab operations. Planning, executing and documenting the qualification of anew lab equipment in cGMP regulated environment. Developing and maintain an equipment qualification project plan as part of the commissioning of new laboratory facilities. Writing IQ/OQ & PQ equipment validation protocols and associated reports. Planning and conducting routine cals. and qualification of lab equipment. Generation and resolution of protocol discrepancies and deviations as required. Execution of validation activities and oversight of vendor activities. Protocol and report writing for test method qualification. Requirements BSC Degree in Engineering or Science related subjects. Minimum of2 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. 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. Interested candidates should submit an updated CV, marked for the attention of Audrey. email@example.com or 00353 21 4297900. This job originally appeared on RecruitIreland.com.
113 days ago