For Cleaning Validation Suppport services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Science or Engineering and five (5) years of experience in cleaning validation activities within the Pharmaceutical & Medical Devices Industry.
Bilingual: Spanish and English Soft Skills: Excellent Communication skills, and Positive attitude. Shift: Administrative and according business needs. Experience in: Developing cleaning validation studies, protocols and reports.
Manufacturing process risk assessment Implementing data integrity requirements GMP & GDP regulations.
The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members.
In other words, being a customer service pro is one of your (many) talents.
Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table.
Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Active participation in Cleaning Validation team meetings to provide input on project timeline considerations, activities, escalations, and status of assigned.
Evaluate and understand cleaning processes.
Evaluate paper forms, protocols, process, and equipment cleaning instructions to transfer them to a new digital platform.
Assess work center equipment capability and cleaning instructions for improvement purposes. Serve as Subject Matter Expert to develop cleaning validation protocols, reports, executable instructions, and implementation of data integrity.
Revise and approve cleaning strategy documents.
Participate in the revision of the cleaning documentation records related to the manufacturing stages and steps. Issuance change control and present it in the Change Control Board to pursue approval of the change.
Review documentation associated to the cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, etc.).
Revise equipment cleaning instructions while transferring to a new digital platform.
Revise SOPs related to the cleaning program and requirements.
Participate /lead the data integrity assessment and actions for the cleaning program. Lead training activities provided to manufacturing operators. Support On Call rotation for cleaning execution activities.
Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
Comply with additional tasks requested by supervisor WHO WE ARE: We are a Service Provider company different from the rest.
We pride ourselves in how we treat the most important piece of our company's puzzle: you!
We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!).
Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?
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