QC Lab Support Validation Engineer
| Job Type | Contractor |
| Area | Westmeath |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2345 |
| Job Views | 158 |
- 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.
- 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.
