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Hired by Matrix, Inc · 3 days ago

Validation Specialist – Engineering

Wilson, NC

Contract

Onsite

Senior Level

$85/hr - $85/hr

5+ years exp

Hired by Matrix, Inc is a pharmaceutical company seeking a Validation Specialist - Engineering to join their team. The role involves implementing and coordinating validation programs for equipment and facilities in compliance with cGMPs and FDA requirements, along with developing and executing validation protocols.

Human ResourcesMarketingStaffing Agency

Growth Opportunities

Responsibilities

Responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance to cGMPs, FDA requirements and company policy

Development and execution of equipment and facilities validation protocols is the primary responsibility

Inherent is the responsibility to ensure the accuracy and completeness of each validation study and that each study is acceptable to FDA standards and requirements

Participate in the commissioning, qualification and start-up of various pharmaceutical cGMP process and packaging equipment, utilities & facilities

Coordinate, develop and prepare installation, operation and performance qualification protocols for production equipment and production related facilities validation. Including the validation of manufacturing and packaging equipment, HVAC, Compressed Air and Purified Water systems

Coordinate and perform the execution of validation studies. Prepare validation reports, including data analysis, conclusions, and recommendations

Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle

Able to perform field execution of qualification test cases and protocols

Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met

Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following: Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities

Perform other related assignments and duties as required and assigned

Qualification

CommissioningQualificationCGMP knowledgeValidation experienceProcess control systemsDocument preparationMulti-taskingEffective communication

Required

5+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry

Bachelor's degree in engineering, a scientific discipline, or a degree in some other discipline

Knowledge of cGMPs and FDA guidelines and regulations acquired through education, experience and training

Experience with commissioning & qualification of equipment & facilities is required

Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, and computer systems validation is an asset but not required

Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, and Historians) and building automation systems are considered an asset

Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, and IOQs

Ability to handle multiple projects and work in a fast-paced environment

Strong multi-tasking skills

Effective written and oral communication skills

High proficiency in preparing documents with MS Word and editing Access Data Bases