Instrument Validation Specialist – Level I
Primary responsibilities include, but are not limited to: 
 

• Manage equipment assets at multiple locations
  

• Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions 
  

• Participate in computer system validation activities associated with new or upgraded equipment or software packages. 
  

• Originate and progress Deviations and Change Control records. 
  

• Perform and document investigations and assist in developing and implementing CAPA plans 
  

• Contribute to new SOP drafting, implementation, and revisions. 
  

• Represent the laboratory on all aspects of laboratory equipment during audits. 
  

• Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.
  

• Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
  

• Willingness and ability to quickly upskill in Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation and other document and/or asset repositories.
  

• Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment. 
  

• Support primarily the qualification/validation of computerized analytical systems as per current guidelines. 
  

• Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers. 
  

• Perform any required change control during the life cycle of a computerized system.
  

• Decommission systems as required as part of the equipment qualification/validation life cycle.
  

• Manage the capital purchasing and initial installation of computerized analytical systems prior to validation. 
  

• Participate in various data integrity and lab modernization activities as required. 
  

• Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus). 
  

• Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.

General Requirements

• Bachelor’s degree in biological or chemical science and/or engineering plus 2-4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification

• Experience working in a GMP environment and maintaining laboratory equipment.
  

• Highly organized, strong communication skills.
  

• Capable of working independently.
  

• Solutions orientated mindset with the ability to handle multiple high priority tasks at one time.
  

• Ability to succeed in a dynamic environment; flexibility to respond to changing priorities.
  

• Awareness to independently prioritize tasks and responsibilities based on actual or perceived level of importance and/or potential impact to the GMP environment.

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