What are the responsibilities and job description for the Validation Manager position at SPINO?
Lab Solutions Manager (IT Systems Validation Consultant/CSV)Contract
Duration:12 months
Immediate start date
Location:Exton , PA
As part of the Digital and Transformation (D&T) team, the Lab Solutions Manager is a hands on system administrator primarily responsible for administrating, supporting and implementing the LabVantage (LIMS), Waters Nugenesis SDMS and the Lab Monitoring Systems(WebCtrl and Lighthouse) within Client place. The Lab Solutions Manager will work closely with the D&T LIMS development staff, other D&T team members, QA, Metrology and Lab Operations to ensure these systems meet the needs defined by Global Analytical Services which include maintaining cGMP compliance.
Essential Duties and Responsibilities:
- Administer, support and implement server based lab applications within the Analytical Labs to ensure systems are operational
- Participate in rotating “on-call” support to provide 24 hours/7 days/365 days per year application support. This includes coordinating support with the software vendors as needed.
- Maintain systems in a compliant environment to control costs, reduce risks and improve productivity
- Collaborate with Lab Operations and Metrology to ensure system needs within Analytical Services are communicated
- Assist with the development and implementation of systems to support infrastructure at all site laboratories globally to support the roll out of major key initiatives for lab automation and compliance
- Write, execute IQs, OQs, PQs, and validation protocols as necessary
- Initiate and review documents such as laboratory investigations, work instructions, SOP’s, etc., as assigned
- Ensure that new systems and software are properly integrated with existing processes and capabilities
- Assist and participate in audits
- Perform other tasks as assigned
Basic Qualifications:
- Bachelor’s degree or equivalent experience in IT, Laboratory systems or a Scientific field
- Minimum 10 years of industry experience
- Minimum 5 years of Lab based systems
Preferred Knowledge, Skills and Abilities:
- Working knowledge of LabVantage (LIMS) configuration, new feature deployment and Jasper Reporting Platform a must
- Experience working in cGMP compliant Analytical Lab with knowledge of Part 11 compliance and validation a must.
- Experience with Oracle, Microsoft SQL Server, JBoss Web Server and Microsoft Application Development Tools preferred
- Working knowledge of LabVantage RCP Interface, ELN and SDMS modules a plus
- Working knowledge of any or all of the following applications Waters Nugenesis SDMS , Waters Empower, an LMS such as WebCtl or LMS Pharma a plus
- Working knowledge of various analytical instruments software various analytical instruments software desired
- ITIL Foundations Certification, A , COMP TIA, MCSD, MCDBA, Oracle OCA or OCP, a plus.
- Ability to work with staff, peers, and others in a fast paced, team oriented, cross functional, multi-cultural environment to accomplish established goals and objectives as well as identify and resolve problems.
- Shows initiative and ability to work independently
- Strong analytical, problem solving and decision making abilities
- Excellent written and verbal communication skills required.
Travel Requirements:
- Must be able to travel up to 10% of the time
Job Type: Contract
Pay: $60.00 per hour
Expected hours: 40 per week
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- Systems Validation: 10 years (Required)
- system administrator: 4 years (Required)
- Lab based systems: 5 years (Required)
- Laboratory information management systems: 5 years (Required)
- cGMP: 4 years (Required)
Ability to Commute:
- Exton, PA 19341 (Required)
Work Location: In person
Salary : $60