Design Verification Lead
Carolina, PR, Puerto Rico
Contracted
Pharmaceutical
Experienced
For Design services in the Engineering area
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor's Degree in Engineering (Mechanical or Chemical is preferred) and (5+) years of experience within the pharmaceutical or large-scale facility design.
- Bilingual (English & Spanish).
- EIT or Professional Engineer (PE) license (preferred)
- Project Management Skills
- Shift: Administrative and according to business needs.
- Experience in:
- Capital Projects delivery processes, and A/E design activities
- Experience in GMP or regulated environments (pharma/biotech).
The Personality Part:
- If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead, then this is the job for you! Sprinkle on a love for the scientific method, teamwork, and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Lead in the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
- Be responsible for the overall design delivery for capital project(s).
- Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
- Direct the development of the design requirements.
- Assist in development and maintenance of the design schedule to meet the project needs.
- Participate in the selection of the A/E firms.
- Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
- Expedite design decisions and coordinate information flow between the design team and system owners.
- Be responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer.
- Be responsible for design activities and governance, resolving design-related problems.
- Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
- Assist in the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices.
- Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
- Work with Engineering Tech Center resources, local engineering resources, and other key project team technical/constructability resources to address and resolve design issues.
- Ensure replication is achieved during design when applicable.
- Support the Project Manager for value engineering exercises efforts to maximize project opportunities.
- Review design-related invoices prior to approval and participate in KPI reviews/assessments.
- Participate in the selection of the verification professional services.
- Accountable for the development of the Project Verification Plan, Traceability Matrix, and risk assessments (not necessary lead the execution).
- Coordinate verification for the Project Manager during the verification phase of the project.
- Accountable for the discrepancy tracking and management in the Verification phase.
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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