Validation Specialist
RCM Technologies
- Dorado, PR
- Permanente
- Tiempo completo
Job Function: Develops and reviews documentation and procedures, and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.
Job Type: Full Time 3-6 months Contract
Location: Dorado, PR (On-Site)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 looking for a Validation Specialist for our medical technology company client.Primary Responsibilities
- Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
- Responsible for reviewing and developing process validation protocols and reports.
- Support other functional areas during the validation activities.
- Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.
- Design and develop in-process and receiving quality systems for new processes and components
- Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required
- Define gages, tools and equipment for the test methods developed.
- Generate manufacturing instructions for new processes being developed
- Work cross-functionally with other departments to accomplish PD tasks
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System
- Experience with Process validation (IQ/SQ, PC, TMVs)
- Experience with Process development
- Experience with Medical Device documentation
- Experience with Microsoft Office Suite.
- Highly capable of developing, executing, and reviewing validation life cycle protocols.
- Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments.
Minimum 3-5 years of related experienceEqual Opportunity Statement
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.