Job Page
Junior CSV Engineer 1419
Co. Louth
About SimoTech
SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
Why SimoTech
What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
Junior CSV Engineer 1419
SimoTech have an opportunity for a Junior CSV Engineer to join our team, working on a state-of-the-art greenfield biotechnology site based in Co. Louth. Candidates must have 1 – 3 years’ experience working in a CSV environment within the biotechnology or pharmaceutical industry. The successful candidate will be required to work onsite 5 days per week.
Key Responsibilities
- Management of Automation document periodic review program:
- Liaise with engineering document control on periodic review schedule.
- Initiate review on document control system (Master Control).
- Update document template if required.
- Liaise with relevant engineers to gather updates where required.
- Progress and drive documents through review and approval stages.
- Management of Automation lifecycle documents through revision, review and approval as required:
- Receive redlined documents from engineers.
- Update document templates if required.
- Initiate reviews on document control system.
- Progress and drive documents through review and approval stages.
- Assist with Automation document updates (lifecycle and SOP) in relation to NPI projects:
- Receive update requirements or redlines from engineers.
- Update document templates if required.
- Initiate reviews on document control system.
- Progress and drive documents through review and approval stages.
Qualifications
- Third level qualification in a relevant field (Engineering, Science, etc.).
- 1 - 3 years relevant experience within the biotechnology or pharmaceutical industry.
- Working knowledge of cGMP requirements in the pharmaceutical or similarly regulated environments.
- Excellent accuracy and attention to detail.
- Good knowledge of relevant computer packages e.g., Microsoft Word, Excel, SharePoint, PowerPoint.
- Proficiency in the use of Documentum, Trackwise, Maximo or similar applications is an advantage.
- Planning and organisational skills are required to plan, execute, and track documentation control and to adjust to changing priorities as required.
What SimoTech Can Offer
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
By submitting my data (CV), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech Privacy Statement which I have read.