LSC have a great contract opportunity for a Lab Systems CSV Engineer to join a leading biotech company based in Cork.
If you have 3+ year of experience in supporting and validating lab equipment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Type of Role: The Lab Systems CSV Engineer will be responsible for the execution of Laboratory Computer System Validation activities within the AIQ framework.
- (Analytical Instrument Qualification)
- The successful candidate will be part of the Lab Services Team which will deliver validation elements for lab systems.
- Individual is expected to be self-motivated and develop an understanding of the business.
- Experience of working in a pharmaceutical manufacturing operation or a regulated environment is desirable.
Role will involve:
- Manage lab equipment validation projects from software install to business release
- Work with ELM team colleagues to deliver validation elements of Laboratory capital projects.
- End to End ownership of Change Controls and their results.
- AuthorReviewApprove qualification documents for lab systems.
- Work with site teams on generation of requirements andor configuration of specifications and IOQ test protocols.
- Execution of IOQ protocols for lab analytical instruments.
- Generation of risk assessments.
- Be a key SME for the AIQ process for all GMP audits
ABOUT YOU - ARE YOUR SKILLS A MATCH?
Essential:
- Minimum 3 years' experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
- Work with ELM team colleagues to deliver validation elements of Laboratory capital projects.
- End to End ownership of Change Controls and their results.
- AuthorReviewApprove qualification documents for lab systems.
- Work with site teams on generation of requirements andor configuration of specifications and IOQ test protocols.
- Execution of IOQ protocols for lab analytical instruments.
- Generation of risk assessments.
- Be a key SME for the AIQ process for all GMP audits
- Knowledge of 21CFR Part 11 requirements and data integrity guidelines is desirable
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
- Self-motivated, detail-oriented and excellent organizational and time management skills
- Capable of relating well to other people with whom s/he comes in contact, both within and outside of the laboratory area
Bring your expertise to this opportunity-review the role and apply today.
WHY LSC? LSC work exclusively in the Life Sciences sector. Founded and run by contractors, we understand contracting first-hand and have created a unique approach to make the process as smooth as possible, so you can focus on delivering your best work.
With over 23 years' experience supporting the industry, we bring deep sector knowledge and long-standing client relationships. At LSC, we partner with you for the long term, not just the duration of your contract. We are committed to building lasting relationships and will work closely with you to ensure you are placed on projects that challenge, develop, and reward you throughout your career.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply. Apply via this advert or contact Paul O'Driscoll on 021 4777329 if you have any questions about this role. Find out more about working with LSC at lscconnect.com
