CSV and CQV Consultants (Packaging and Facility) Job at RCM Technologies (USA), Inc.
Job Title: CSV and CQV Consultants (Packaging and Facility)
Job Function: SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
Job Type: Full Time 6 month contract
Location: On site Manati, PR
About RCM:
Scope of Job
Primary Responsibilities
Disclaimer
Job Function: SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
Job Type: Full Time 6 month contract
Location: On site Manati, PR
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 several experienced CSV and CQV consultants to support a Packaging Project for our pharmaceutical client in Manati, Puerto Rico.
Primary Responsibilities
- Computer System Validation (CSV) and System Development Life Cycle (SDLC)
- Individuals that have worked in validating and qualifying the following areas:
- Checkweigher
- Labeling (Packaging)
- Conveyor (Manufacturing)
- Vision System
- HVAC (Environmental)
- Facility (Process)
- Serialization Equipment CQV/CSV
- Development and Execution of Protocols for each of the respective areas
- Looking for consultants for two shifts
- Shift 1 - AM (7am - 6pm) or
- Shift 2 - PM (1pm - 12am)
- Experience in direct process / manufacturing areas.
- Experience in Design Documentation (URS/FRS, DS), IQ, OQ, PQ protocols development and execution, deviations, and reports generation.
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Technical Writing skills and investigations processes.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Bachelor's Degree in Science or Engineering with minimum of 5 years of experience in direct pharmaceutical, medical device, or biotechnology industries.
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.
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