Job Title: IS/Automation Tech
Job Function: IS/IT Support
Job Type: Full Time Contract
Location: On-site support Juncos. PR
About RCM:RCM Life Sciences & IT is a leading provider of Engineering Services and IT Business Solutions 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 and PR.
Scope of Job- RCM is seeking an experienced IS Technician for our biotechnology client.
Primary Responsibilities- Troubleshoot (Operational, Cyber and/or Security Related), repair and/or restore manufacturing equipment automation and / or Process Control Systems in compliance with all applicable industry standards, regulatory standards, and FDA standards.
- Support the maintenance teams and project teams in the implementation of Cyber/Security/Antivirus changes in automation systems as part of change controls, CAPAs, work orders, etc.
- Provide technical assessments " Cyber/Security/Antivirus/Back up related for Equipment/ System Computers.
- Support the startup and validation of new systems and/or equipment automation systems from " Cyber/Security/Antivirus/Back up standpoint.
- Review technical specification documents to ensure their inclusion of automation requirements/specifications per AML standards from Automation "Cyber/Security/Antivirus/Back up standpoint on Equipment computers.
- Complete technical and safety trainings per requirements of the job and organization as specified in training module.
- Available to work on different Operational shifts, weekends and/or holidays as determined by business.
- Assist the manufacturing plant during FDA and other regulatory agency inspections. providing technical support and or assessments in response to the FDA and other regulatory agencies.
Qualifications- Thorough knowledge of GMP regulations and guidelines
- Working knowledge in automation system (e.g., vision system, sensors, data acquisition, PLC, robotic, lasers) is aplus.
- Working knowledge of equipment mechanical process (e.g., servomotors, pneumatics)
- Knowledge of validation processes and understanding of validation protocol execution requirements
- Effective communication (verbal and written) at all levels
- Excellent communication skills, both verbal and written
- Detailed knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance
- Knowledge of general software and database concepts
- Knowledge of infrastructure technology and platforms
- The ability to work both independently and with teams at various levels in the organization
- Excellent organizational skills and attention to detail and accuracy
- Five or more years of experience within a regulated environment
Education & Certifications- Bachelor's Degree in an engineering or science related field (or equivalent combination of education and experience) and four years of experince in related environment.
Equal Opportunity StatementRCM 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.
DisclaimerThis 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.
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Last updated on Sep 19, 2023