Principal Validation Engineer

For CQV services in the Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree with eight (8) years of experience as a C&Q Engineer within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative, and according to business needs.
• Experience in:
• CQV Validation Expert: Risk-based qualification methods (ASTM E 2500) for pharmaceutical manufacturing equipment and utilities
• Sterilization & Cleaning Specialist (SME): CIP and SIP processes
• GMP Document Controller: Validation Protocols (IQ/OQ/PQ), Risk Assessments, and leading Root Cause Analysis (RCA) for quality issues.
• Engineering Project Support: P&IDs and FAT/SAT.

The Personality Part:

• Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Review and/or Approve Lifecycle Documents, including but not limited to User Requirements, Risk Assessments, Data Integrity Assessments, Commissioning and Qualification Plans, Validation Plans, Installation, Operational and Performance Verification (included but not limited to Clean Utilities such as APR, WFI, SCL, and PW) protocols and reports
• Support field execution of commissioning/integration testing required by the C&Q Plan.
• Evaluate and approve protocol discrepancies/deviations with direct support in the Root Cause Analysis.
• Review engineering change notices and evaluate/propose modifications to the qualification strategies
• Participate in engineering design phases and propose strategies to assure successful qualification and start-up. Anticipate potential pitfalls based on regulatory /compliance guidance
• Apply Risk-Based Validation approaches based on Amgen Standard Operating Procedures and industry guidance
• Create and/or revise SIP drawings (~65) for Upstream and Downstream impacted circuits.
• Participate in project weekly meetings, such as Detail Design Technical Meeting and Slowdown Window Workshops for Upstream, Downstream, and Clean Utilities.
• Participate in risk assessments to identify potential hazards and implement appropriate controls, including, but not limited to, reviewing and approving the risk assessment report.
• ⁠Process and Equipment understanding, which includes P&IDs walkdown with engineering and determination of impacted circuits (product/non-product contact).
• Provide SME support to engineering phases, including basis of design, detailed design, risk assessments, and align the commissioning execution strategy with the CQ Service Provider (e.g., FAT, SAT, Set to Work, Safety, Maintenance, Receipt Verification, Installation Verifications, Functional Testing, etc)
• Clean In Place (CIP) expertise, which includes, but is not limited to, cycle development, cleaning studies, worst case determination, protocol, and report preparation.
• Steam In Place (SIP) expertise, including but not limited to Thermal, Biological Indicator, and Microbial Challenge testing to assess the effectiveness of the sterilization process and protocol, and report preparation.
• Evaluates and documents the commissioning and qualification impact to proposed critical system changes through the Change Control Program, if necessary.

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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