CSV Engineer
The Staffing Resource Group
- Portsmouth, NH
- $68.00 per hour
- Contract
- Full-time
Location: Portsmouth, NH
Industry: Pharmaceutical
Hours: M-F: 8am-5pm (onsite)
Salary: Up to $68/hr. paid weekly (Benefits Available)
Employment Type: Contract - possible extensionEnvironment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.Duties may include any of the following:
- Manage, document, and assess the software changes throughout the SDLC following procedures.
- Author, Review, Approve and Execute CSV life cycle documentation
- 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
- CSV /Automation experience of 5+ years
- Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / BAS (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
- 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
- Experience within pharmaceutical or related regulated industry is highly preferred