Instrument Validation Specialist – Level IPrimary 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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Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
