Address
Form of work Company Description
Pharma
Job Description
This role is a senior CSV engineer requirement.
- CSV /Automation experience of 5+ years
- Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / Client (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
- Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
- Experienced at working independently as well as in a team-oriented, collaborative environment is essential
- Author, Review, Approve and Execute CSV life cycle documentation
- Experience working with and programming/commissioning/validating Delta V software platforms
- Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems
- Manage, document, and assess the software changes throughout the SDLC following *** procedures.
- Knowledgeable of S88 Batch Standard is preferable
- Recipe management DeltaV software development and testing is preferable
- MES Recipe authoring and testing is preferable
- Implementation and validation of QC system is preferable
- Experience with Kneat is preferable
- Strong verbal and written communication skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
