Computer Systems Validation Specialist Job Description
The ideal candidate will be responsible for managing regulatory compliance programs and ensuring adherence to policies and procedures. This involves promoting a risk-based and efficient approach to compliance activities.
About the Role:
* Deliver top-tier computer systems validation for capital projects.
* Promote automation validation standards across projects.
* Collaborate with site compliance and validation teams to coordinate activities.
* Ensure compliance with Computer Systems Validation, Systems Development Lifecycle, Cyber Security, and Data Integrity to maintain the quality of pharmaceuticals.
* Act as a Subject Matter Expert on computer validation for capital projects.
Key Responsibilities:
* Ongoing validation, training, and compliance support.
* Represent compliance activities to internal and external auditors.
* Assist in developing audit responses and engage with local quality organizations as needed.
* Identify and address IT and Operational Technology compliance risks.
* Conduct risk assessments for new technologies or significant changes.
Requirements:
* Bachelor's Degree in Computer Science, Engineering, Regulatory Compliance, or a related field.
* 2+ years of experience in compliance activities for capital projects.
* Strong knowledge of regulatory requirements related to computerized systems validation.
* Familiarity with ISA S95 and S88 Standards in a Good Practice environment.
Benefits:
* Opportunity to work with a dynamic team.
* Professional development and growth opportunities.
* A competitive salary and benefits package.
Working Conditions:
* This role requires travel up to 25% of the time.
* Must be willing to adapt to changing priorities and deadlines.
Contact Information:
Please apply through our website.