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Instrument Validation Specialist

Remote in Rahway, NJ, US • Posted 5 hours ago • Updated 5 hours ago

Contract W2

On-site

Fitment

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Job Details

Skills

Science
Computerized System Validation
Software Packaging
Corrective And Preventive Action
SOP
Technical Drafting
Auditing
Regulatory Compliance
Good Manufacturing Practice
Policies and Procedures
Writing
SAP
LAMP
Documentation
Collaboration
Metrology
Testing
Process Improvement
Training
Technical Support
Change Control
Purchasing
Data Integrity
Management
Analytical Skill
Instrumentation
Pharmaceutics
FOCUS
Chemistry
Laboratory Equipment
Organized
Communication
GMP

Summary

Metrology Specialist I

Kelly Science and Clinical FSP is currently seeking a Metrology 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.

Location: 100% On-site in Rahway, NJ

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 Merck 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.

Calibration Focus:

Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.

Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.

Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.

Support the purchase, installation, and equipment qualification of new laboratory equipment.

*** There will be training opportunities to support Validation*** Validation activities are included below

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 Level 1:
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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10105282
Position Id: 878174
Posted 5 hours ago

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Instrument Validation Specialist

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