Title: Lab System Validation
Location: West Point, PA
Duration: 7 months
 

• Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Experience of CSV Validation in any one of the Lab systems is must.
• Should worked in pharmaceutical domain and its related knowledge is must
• Good communication and technical writing skills are a must
• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
• CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
• To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
• Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
• Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
• Exposure to Regulatory Audits and Remediation activities
• Ensure the CSV artefacts are in line and meets regulatory requirements
• Preferred Experience in Agile Development
• Knowledge on working in Jira / Service Now
• Adaptation to AI is preferred.

 
Testing (in addition to above)

• Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
• Prepare and execute ?TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
• Knowledge on working in Jira, HP ALM or any automation testing tools.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 46.43/hr.