Design Verification Lead

Reposted 4 Days Ago
Be an Early Applicant
Carolina, PRI
In-Office
Senior level
Pharmaceutical
The Role
Lead and coordinate design verification for pharmaceutical/medical device projects: develop design requirements, maintain schedules, liaise with A/E firms and construction, oversee verification providers, manage discrepancies, collect metrics, and complete verification closeout.
Summary Generated by Built In

 For Design services in the Engineering area

WHAT MAKES YOU A FIT: 

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?

Skills Required

  • Bachelor's Degree in Engineering (Chemical or Mechanical) with five years engineering experience in pharmaceutical or medical device industry.
  • Bilingual: English and Spanish.
  • EIT or Professional Engineer (PE) license.
  • Experience with OSD and API operations and processes.
  • Pharma project experience.
  • Project management and budgeting experience.
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
Year Founded: 2008

What We Do

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 We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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