GxP Lab Computing Engineer (Contract)

GxP Lab Computing Engineer The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal support team.RequirementsRequired Skills:Excellent customer service skills complemented by an ability to listen to and interpret client requestsAbility to troubleshoot complex instrument and technology issuesStrong oral and written communication skillsAbility to identify, track and complete tasks for multiple projectsKnowledge of laboratory safety practices as defined by the company and/or customer’s site safety codeResponsibilities:As a Lab Computing Analyst, beneficiary would perform following key responsibilities:Requirements Management and onsite Validation/Compliance supportIT ConsultingCustomer LiaisonOnsite Lab IT SupportRequirements ManagementUnderstand problem statement/challengesDefine scopeGather requirements.Assist with Validation/Compliance activities (IOPQ) as required.Analyze current state business processes and requirements.Assist in building plans for process improvementIT ConsultingAnalyze gaps/opportunities for improvement based on industry Best PracticeEvaluate Industry trends to identify areas for optimizationEvaluate vendor solutions and facilitate demos of prototypes as Proofs of ConceptRecommend process improvements that fit business needsCustomer Liaison:Meeting with internal/external service groups/leadsLiaise between System/Lab owners and third parties to coordinate best times for servicesProvide weekly planning schedules for review at status meeting with customer leadsMonthly Operational review meetings/ Quarterly metrics reporting with department headsOn Site Lab IT Support:Perform break/fix support for all Instrument connected systemsImplement Windows based security policies as requiredEnsure adherence to client’s corporate policies through periodic reporting & compliance programsActs as the technical support contact for field service engineers and external vendorsProvide technical subject matter expertise for new system validation and change managementCreate and maintain a physical inventory of lab equipment, PC’s, software, and any other information pertinent to the environment if applicablePerform system preventative maintenances based on client’s schedule, if applicableRequirementsBachelor’s/Master’s degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, ChemicalAt least 5 years of directly relevant experience, including:At least 3 years in software development and testing.At least 2 years of experience in business requirement analysis and gathering.Demonstrated domain area knowledge.Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client’s confidence and trust.Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry:Drug Discovery & Development ProcessesClinical study planning & Data managementLab WorkflowsChemical & Biologics material ManagementSample ManagementRobotic Systems Integration & QualificationOperations KPI and Metrics trackingOptional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820Technical Skills:Operating System familiarity with at least 1 of the following: Unix, Windows, MVSSoftware Methodology familiarity with: Object Oriented Programming, Structured ProgrammingSoftware Development Process familiarity with: Waterfall, AgileChange Control Management and Risk ManagementOffice Tools proficiency required in : MS Word, Excel, PowerPointOffice productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint