IT Engineer

Job Title: IT Engineer
Job Type: Direct Placement
Location: Humacao, Puerto Rico

About RCM:
RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.

Scope of Job

• RCM is seeking an IT Engineer for one of our pharmaceutical clients in Puerto Rico. The IT Engineer will be responsible for updating and maintaining the client's computer system in compliance with data integrity as per the regulatory agencies. The IT Engineer is also responsible for the software validation activities from development to execution.

Primary Responsibilities

• Implementing risk-based validation approach to ensure IT (GxP) software and applications comply with regulations and industry guidelines.
• Maintain computer system in compliance with Data Integrity as defined by FDA.
• Developing and executing software validation projects to meet validation deliverables.
• Facilitating the resolution of key quality validation issues by assisting in failure investigations, assisting in problem resolution, and providing feedback to IT development and infrastructure teams.
• Supporting audits as a technical subject matter expert for software and application validation.
• Supports audits performed by governmental competent authorities (e.g., US Food and Drug Administration (FDA) inspections), Notified Body audits, and internal/corporate audits.
• Reviews and approves updates to quality system and IT validation documents.
• Interacting frequently with Quality, Information Technology, Manufacturing, R&D Validation and Verification laboratory and other business units to support project and objective completion.
• Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
• Conforms to, supports, and enforces all Company policies and procedures.

Knowledge, Skills, and Abilities

• Knowledge in ICM Open Lab Program or equivalent (Laboratory Data Integrity)
• Knowledge in Serialization process including Video Jet and Cognex cameras.
• Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects.
• Prepare validation documentation packages and complete validation of Computerized Laboratory Systems.
• Link between Client and computer service providers

Education & Certifications

• Bachelor's degree or higher in a Science or Engineering (computer science, chemical engineer, industrial engineer, or engineering Science)
• At least Three (3) years' experience in computer system validation for pharmaceutical industry

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job, duty, and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.




RCM Technologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCM encourages applicants of all ages.

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