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location: North Billerica, Massachusetts
job type: Permanent
salary: $110,000 - 125,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
This resource will serve as the IT Validation lead on key technology initiative's during implementation and post Go-live, primary focus on new ERP implementation in 22/23. This role will partner with Integration Team to author, review, and approve company CSV documentation and update impacted SOP's for the Information Technology group. Responsible for CSV, IT Change Control, CAPA and IT Procedures. Provides support and expertise on project teams for impacts on our regulated technology environment. This role will provide application support as needed to support business teams in Manufacturing, Quality and R&D.
- Experience as a CSV lead in Life Science industry
- Experience bring a cloud based ERP technology live and maintaining validation state post go-live
- Experience reviewing Validation protocols, Traceability Matrix & other validation documents
- Good understanding of Pharma guidelines including GAMP, 21 CFR Part 11 etc..
- Serve as CSV Lead representing company validation standards and coordinating reviews, sign-offs with various company functions and quality group, partnering with project Integration team to define, execute and operationalize validation that includes
- Ability to work with multiple stakeholders and project teams
- Defining Post Go-live validation strategy for Cloud based SAAS solution to support patching/SW version releases
- Create or help support and maintain the requirement & test traceability matrix
- Support the team in developing test strategies, procedures and scripts to ensure adherence to CSV standards
- Development of test reports and summaries to support the release to production.
- Provide input to project teams on validation work schedule along with ongoing status updates to project team to ensure successful project delivery
- Effectively partner with teams to define and develop a strategy to validate and maintain the validated state of Quality System applications
- Partner with the leadership team to make validation decisions, participate in software implementations, analyze risk-based testing, and participate in vendor recommendations
- Maintain ownership of the validation elements within the CSV automation tool
- Good communication and interpersonal skills
- Execute/support the execution of impacted SOP updates through the QMS document management process
- Maintain knowledge of compliance and ensure all work activities are conducted within the regulatory requirements, related policies and procedures, and corporate objectives
- Responsible for executing good development and documentation practices
- Effectively evaluate and shift priorities appropriately based on multiple considerations and changing demands
- Assist in training and knowledge sharing for areas of expertise with other colleagues
- Provide application support as needed to support business teams in Manufacturing, Quality and R&D
qualifications:
- 3+ years of relevant experience
- Previous GxP / Pharma exp. is required.
- Experience with IQ/OQ and Validation activities
- Documentation:
- Validation Plan, Updates to URS, SDCS, SOPs, Training documentation, etc.
- Authoring / Updates of Test Scripts (OQ) and
- OQ Execution Report, Val Summary Report
- Document deliverables per LMI GxP SOPs
- Validation / Qualification:
- Dry run of OQ scripts in DEV
- Execution of IQ/OQ in VAL as needed
- Execution of IQ/SRT (System Readiness Test) in PROD as needed
skills: SOP, ERP System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.