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Job Details


Validation Manager
Salt Lake City, UT  Posted: 9/22/2020

Details:

Validation Manager
This full-time role will focus on qualification/requalification of facilities, utilities, manufacturing and analytical equipment.  The successful candidate will lead the equipment validation effort, working closely with external contractors (if applicable), and internal  equipment subject matter experts.  The facility and utilities include GMP labs and cleanrooms, process gases, and autoclaves. The manufacturing equipment includes cell processing, harvest, aseptic filling, and labeling of cell therapy products. The successful candidate will work with the development, quality, and manufacturing teams to design, test, integrate and implement all processes, equipment, utilities, and documentation following cGMP and QbD principles. True to a startup, this position may require one to utilize other broad and variable skillsets to accomplish our primary objectives.
Responsibilities:
·         Lead validation effort (including facilities, utilities, manufacturing and analytical equipment)
·         Assist with software, automated systems and controls validation
·         Primary interface with external validation contractors/firms
·         Provide tracking and organization of equipment validation documentation and activity
·         Provide regular updates to internal team on validation progress
·         URS, DQ, and risk assessment generation
·         FAT, SAT, IQ, OQ and PQ creation and execution
·         Temperature mapping
·         KAYE validator use
·         Knowledge of system validation “life-cycle” concept
·         Integrate Quality-by-Design (QbD) principles and participate in risk assessments for the process, personnel and equipment
·         Assist with development of system boundary diagrams
·         Data analysis and clear communication of results, including appropriate cGMP documentation for eventual validation package submission and regulatory inquiries
·         Demonstrate a high level of initiative in troubleshooting data analysis
·         Develop and implement protocols and procedures that embody best practices in biologics manufacturing (cGMP, QbD)
 
Basic Qualifications:
·         B.S. in life sciences or engineering
·         5-8 years of experience in biologics or pharmaceutical industry
·         Effective time management skills
·         Self-motivated with focus on continuous improvement
·         Comfort working in the fluid structure of start-up biotech
·         Integrity, confidence, and passion
·         Ideal candidate has experience in validation of biologics equipment for cGMP manufacturing
·         Ideal candidate has experience in formulation and filling engineering and operations
·         Ideal candidate has experience in validation of software, computer and automated systems
 
Benefits:
 
 Offering  a creative, team-oriented scientific environment, along with a strong compensation package that includes salary, stock options, and a comprehensive benefits package.
 
 

Job ID#:

7998

 



 

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