Senior CSV Engineer
Senior CSV Engineer
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Job Description
The Role:
- Senior CSV Engineer
- Dublin
- Onsite / Remote Hybrid
- Permanent or Contractor opportunity
Role Brief:
Responsible for leading and executing validation strategies for key software systems and infrastructure i.e. MES ERP and QMS. Advise clients in planning monitoring and execution of program rollouts. Help optimize and streamline manufacturing related operations. Build relationships with clients and identify new business opportunities.
Skills Brief:
- Strong experience in CSV for manufacturing systems and large-scale applications.
- Full understanding of cGMP requirements including 21 CFR 11 and Annex 11.
- Excellent understanding of GAMP principles and validation concepts
- Experience with Trackwise validation an advantage.
- Demonstrated analytical and problem-solving capabilities.
- Strong technical writing skills.
Person Brief:
- Candidates must have a degree in Computer Science / IT/ Pharmaceutical Manufacturing or a related discipline with 5 years experience in the life sciences industry.
- The ideal candidate will have excellent collaboration and communication skills strong attention to detail and able to communicate and present effectively to various levels of leadership
- Ability to think logically and be proactive.
- Must be flexibly and able to manage multiple priorities simultaneously.
- Must have excellent organizational skills
- The candidate must be available to be onsite in Dublin as required with typically 3 to 4 days per week of onsite work
Opportunity Brief:
This is an excellent opportunity to work with clients who are global leaders in their field helping to develop and improve upon industry leading technology solutions. NNIT Ireland offers a supportive environment committed to employee development and wellness along with a competitive and rounded compensation package which rewards high performers.
Company Brief:
NNIT Ireland are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers including many of the worlds top multinational companies in the medical device and pharmaceutical sectors achieve their Six Sigma and OEE targets.
For over 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway Limerick Leinster and Florida USA.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users OEMs and Technology providers.
Employment Type
Full Time
