Instrument Validation Specialist Position Available In Orange, New York

Job Description:

Job Title:

Instrument Validation Specialist Job Location:

770Sumneytown Pike, West Point, PA 19486

Onsite Requirements:

2-4years of experience participating in the validation of computerizedlaboratory systems or instruments (e.g. system Installation andOperational qualification, Performance qualification) Directexperience operating analytical instrumentation within apharmaceutical or equivalent laboratory (vaccine or large moleculefocus). Ability to thoroughly review and scrutinize validationrequirements through the life cycle of the system.

Job Description:

Responsibilities:

Manage equipment assets at multiple locations.

Gain a working knowledge of laboratory equipment to facilitate withtroubleshooting and/or communicate with the vendor/service engineerto identify resolutions. Participate in computer system validationactivities associated with new or upgraded equipment or softwarepackages. Originate and progress Deviations and Change Controlrecords. Perform and document investigations and assist indeveloping and implementing CAPA plans. Contribute to new SOPdrafting, implementation, and revisions. Represent the laboratoryon all aspects of laboratory equipment during audits. Ensurecompliance with all regulatory requirements (cGMP), internalpolicies and procedures. Customer focused mindset with the abilityto communicate adequately (verbally/writing) to all levels withinthe organization. Willingness and ability to quickly upskill inClient Facilities/Instrument support programs SAP, ProCal, BAS,LAMP, Electronic Validation and other document and/or assetrepositories. Initiate, process and track work orders to facilitatetimely repairs, modifications and moves of laboratory equipment.

Support primarily the qualification/validation of computerizedanalytical systems as per current guidelines. Partner with thebusiness unit in the laboratories, various quality supportoversight, IT technical support, and various software andinstrument vendors/manufacturers. Perform any required changecontrol during the life cycle of a computerized system.

Decommission systems as required as part of the equipmentqualification/validation life cycle. Manage the capital purchasingand initial installation of computerized analytical systems priorto validation. Participate in various data integrity and labmodernization activities as required. Will possess directexperience operating analytical instrumentation within apharmaceutical or equivalent laboratory (vaccine or large moleculefocus). Will have the ability to thoroughly review and scrutinizevalidation requirements through the life cycle of the system.

General Requirements:

Bachelor’s degree in biological or chemicalscience and/or engineering plus 2-4 years of experienceparticipating in the validation of computerized laboratory systemsor instruments (e.g. system Installation and Operationalqualification, Performance qualification). Experience working in aGMP environment and maintaining laboratory equipment. Highlyorganized, strong communication skills. Capable of workingindependently. Solutions orientated mindset with the ability tohandle multiple high priority tasks at one time. Ability to succeedin a dynamic environment; flexibility to respond to changingpriorities. Awareness to independently prioritize tasks andresponsibilities based on actual or perceived level of importanceand/or potential impact to the GMP environment. 3rd party andsubcontract staffing agencies are not eligible for partnership onthis position. 3rd party subcontractors need not apply. Thisposition requires candidates to be eligible to work in the UnitedStates, directly for an employer, without sponsorship now oranytime in the future