Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals. CAI offers you control of your career, your professional development, your growth and path to success.
Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We work in the areas of automation, commissioning and qualification, validation, maintenance and reliability, building commissioning, consulting and information management systems.
Summary: This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
-Prepares/reviews validation documentation related to projects/change controls.
-Manages change controls and other compliance related tasks e.g. non-conformances.
-Participates in the review of current and futre CSV procedures and polices
-Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
-Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
-Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
-Coordinates with other departments or outside contractors/vendors to complete validation tasks.
-Participates in regulatory audits and communicates company’s computer validation policies.
-Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
-Manages projects and prepares status reports using Microsoft project and other communication tools.
-May supervise, lead, or manage lower-level personnel.
Education and Experience:
Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT ---Infrastructure Qualification/validation; will substitute relevant experience for education.
Experience in a GMP environment essential.
Biologics experience highly desirable
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Health insurance, company paid critical illness insurance, Life Insurance, PRSA contribution and more
· Annual profit sharing
· Paid time off
· Continuing Professional Development and Education (internal and external)
· Opportunity to work abroad if desired
If you are interested and qualified for this position, please apply.