Kelly Services
Location
Rahway, NJ | United States
Job description
Kelly Science and Clinical FSP is currently seeking an Instrument Validation Specialist for a long-term engagement in Rahway, NJ with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Instrument Validation Specialist:
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 client 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.
Validation Focus:
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:
Specialist I focus commensurate with degree and experience requirements
Validation: 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
Calibration: Minimum 4-5 years working experience in metrology/information technology / customer service or another relevant field.
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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Job tags
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