Instrument Validation Specialist

4 weeks ago


Dana Point, California, United States Kelly Services Full time
Job Description

As an Instrument Validation Specialist at Kelly Services, you will play a critical role in ensuring the accuracy and reliability of laboratory equipment. Your primary responsibilities will include managing equipment assets at multiple locations, gaining a working knowledge of laboratory equipment to facilitate troubleshooting and communication with vendors or service engineers, and participating in computer system validation activities.

Key Responsibilities
  • Manage equipment assets at multiple locations, ensuring that all equipment is properly calibrated, maintained, and upgraded as needed.
  • Gain a working knowledge of laboratory equipment to facilitate troubleshooting and communication with vendors or service engineers, identifying resolutions to equipment issues.
  • Participate in computer system validation activities associated with new or upgraded equipment or software packages, ensuring that all systems meet regulatory requirements.
  • Originate and progress Deviations and Change Control records, ensuring that all changes are properly documented and approved.
  • Perform and document investigations and assist in developing and implementing CAPA plans, ensuring that all corrective actions are effective and implemented in a timely manner.
  • Contribute to new SOP drafting, implementation, and revisions, ensuring that all procedures are up-to-date and compliant with regulatory requirements.
  • Represent the laboratory on all aspects of laboratory equipment during audits, ensuring that all equipment is properly maintained and compliant with regulatory requirements.
  • Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures, and industry standards.
  • 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.
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-oriented 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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