For Computer and System Validation services in the Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s degree in engineering or science with five (5) years of experience in computerized system validation of the pharmaceutical or biopharmaceutical industry.
- Experience in:
- Design and execution of compliant and efficient validation strategies for system and equipment.
- Development of a technically competent and focused customer service-oriented team.
- Ensure that timely and adequate computerized system validation is performed in conformance with cGMP’s plant procedures, corporate policies, and applicable regulations (FDA, ENEA, DEA, etc.)
- Prioritizes projects and schedules as needed.
- Provides guidance for determining work procedures, preparation of work schedule, and expediting of workflow.
The Personality Part:
- Besides being an CSV Pro, you’re able to analyze data so that not a single inconsistency gets past you (which allows you to be an amazing problem-solver). You’re also a skilled multitasker with an incredible ability to set priorities. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we’re looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Define and execute strategies for IT Computerized Systems, Computerized System
Validation and Data Integrity Compliance for Computerized Systems. - Design and execute Validation Plans and Protocols for Computerized Systems. Perform data integrity risk assessment for new and existing computerized systems.
- Execute Periodic Review activities for the Computerized System in adherence with Site, Regulatory, and Client Corporate Requirements.
- Work both independently and in a team environment with representatives from Quality, Engineering, Manufacturing Operations, and Manufacturing Science & Technology.
- Work within the Office Environment and GMP Controlled Cleanrooms.
- Work within a Facility that requires high diligence and, on occasion, use Personal Protective Equipment (PPE) effectively.
- Coordinate and execute activities as per the approved Protocol.
- Perform computerized systems validation in conformance with cGMPs, plan procedures, corporate policies, and applicable regulations (FDA, DEA, etc.)
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?
Top Skills
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]
