Validation Specialist (pharma)

QualificationsBachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience requiredMaster's Degree preferred Minimum of seven (7) years validation or quality related discipline experience in pharmaceutical environment requiredAssembly and Packaging experience Experienced with regulatory requirements & industry standards for pharmaceutical &/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA & ICH guidance documents requiredDemonstrated experience using root-cause analysis techniques to solve problems preferredAbility to read, write & understand complicated product documentation preferredDemonstrated leadership & project management skills: two-way communication skills with customers (internal/external), project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements preferredAbility to write technical documentation based on equipment manuals preferredExperience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts preferredKnowledge of standard operating procedures with attention to high-level concepts preferredAbility to manage multiple tasks/deadlines & prioritize properly based on process needs preferredDemonstrated strong skills in change management within NN preferredThe PositionPrimary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.Essential FunctionsProvide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocolsOwnership of Change Requests (CR’s) related to project validation responsibilitiesPerform compliance & technical reviews/approvals of protocols & protocol dataAuthor project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentationAuthor & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systemsEnsure compliance of validation protocols executed are aligned with local, corporate & regulatory regulationsLead validation failure investigations & non-conformities utilizing root cause analysis techniquesCreate & modify existing validation procedures & configuration item lists (CIL’s) as requiredWrite/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processesParticipate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipmentIdentify process improvements before equipment, systems or processes are placed under change control during validationBudget oversight as neededContractor scheduling & oversight as neededLeads validation activities assigned by overall project managerOther accountabilities, as assigned