Senior Validation Scientist - Equipment

 For Equipment Validation services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Pharmacy, Chemistry, or Engineering & five (5) years of exposure in the pharmaceutical industry. 
• Shift: Administrative and, according to business needs,
  • Including but not limited to extended hours and weekends.
• Experience in:
  • Advanced Pharmaceutical Manufacturing Expertise in oral dosage form manufacturing processes and specialized packaging technologies.
  • Systems Qualification & Validation of equipment and utilities qualification, including the ability to apply innovative technical theories to validation protocols.
  • Operational Excellence & Troubleshooting
  • Technical Project Leadership: Demonstrated ability to autonomously manage multiple projects, integrating diverse engineering concepts to solve high-level technical challenges.

The Personality Part:    

• If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

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

• Conducts process/packaging equipment installation/operational/performance qualification studies to test their functionality for the manufacture of parenteral and OSD products.
• Conducts critical sterilization/Depyrogenation/bio-decontamination equipment (tanks, autoclaves & SIP, tunnel, isolator), utilities, and facilities qualification studies (Critical utilities/systems include Purified Water, HVAC, compressed gases) to ensure that a system functions to routinely produce results that meet predetermined specifications.
• Conducts temperature/relative humidity mapping qualification studies (cold boxes, freezers, and incubators) to ensure that the system functions as to routinely produces results that meet predetermined specifications.
• Prepares operational qualification assessments to support that validated critical operating parameters are within qualified parameters for specific parenteral and OSD products. Identify and evaluate equipment enhancements to support intended qualified operational ranges.
• Hands-on experience in the use/troubleshooting of validation equipment such as KAYE Validator, thermocouples, and temperature/relative humidity data loggers.
• Supports the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
• Supports process capability and statistical analysis related to equipment performance within the parenteral and OSD manufacturing process
• Serves as Subject Matter Expert for qualifications during regulatory audits (internal and external).
• Supports the periodic review of equipment/system qualifications studies.
• Assists and performs as the liaison person with the Information Technology Department in the implementation and qualification of upgraded equipment control systems and automation initiatives.
• Prepares well-documented protocols for all equipment/utilities qualification exercises in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices.
• Executes and ensures successful and timely equipment/utilities qualification activities as per established protocol in support of the manufacturing operation at the site. 
• Executes activities according to the Time and Event schedule developed by the site team.
• Performs in process test as required, analyze qualification data and generate conclusions based on test results and reports the results in an accurate and timely manner. 
• Performs successful and on-time resolution of incidents and deviations related to equipment/utilities qualification exercises.
• Proposes and formalizes alternatives to enhance the site qualification program.
• Investigates and conducts troubleshooting and root-cause analysis of unexpected trends or results during equipment/utilities qualification activities, implements accurate and timely solutions, and; develop and manages plans as needed. 
• Evaluates deviations with respect to their causes and corrective actions to prevent recurrence. 
• Identifies, plans, and implements quality and productivity initiatives for equipment/utilities qualification activities aligned with business needs and priorities.
• Assures the accuracy and correctness of documentation used during equipment/utilities qualification activities. 
• Trains manufacturing and QC/QA personnel on the qualification documentation. 
• Assures compliance with corporate guidelines and site procedures governing overall operation.
• Maintains documentation in accordance with cGMP and FDA regulations.
• Maintains equipment/utilities qualification program in conformance with department standards and government/corporate regulations.

BEING A FITS PIECE COMES WITH PERKS:

• One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out! 

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?