CSV Subject Matter Expert – 5 positions.
Contract Position-30 Months
Fort Washington PA
Being a long term Position , Client will accept only Local Candidates within PA/NJ/DE areas .
Work with the site engineering, laboratory systems leads, laboratory management, CSV assessors, and auditors to identify, assess, and remediate legacy laboratory systems.
• Develop standard template to ensure effective and efficient CSV • Work with QSE-12 team to remediate laboratory system gaps • Assist in maintaining laboratory systems in a validated state as they relate to GxP CSV automation systems.
• Assist with execution of validation protocols
Education:
BS in Technology related field
Experience/Technical Competencies:
• 3 to 5 years in pharmaceutical engineering, focusing on Computer System Validation.
• 3 to 5 years with pharmaceutical validation experience. LIMS and EMPOWER system experience is REQUIRED..
Job Knowledge/Skillsets:
• Experience with Pharmaceutical Engineering, specializing in Computer System Validation.
• Familiar with GxP systems.
• Fluent knowledge of GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 & 820 compliance.
• Independent worker
• Strong organizational/ facilitation/communication skills.
• Strong verbal, written and presentation skills.
• Strong skills in Interdependent partnering and influencing.
Bala
Accounts Manager
SSAI Technologies LLC | Board: 908 450 9465| Fax: 908 842 0244 | www.ssaitech.com | Email: bala@ssaitech.com | bala.ssaitech@gmail.com
WBE/MBE certified for the State of NJ
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