The Specialist Tech Engineering will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.
FunctionsEnsure utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standardsEnsure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the teamCoordinate technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issuesProvide technical support for the maintenance team during FDA and other regulatory agency inspectionsProvide technical support to the maintenance team in response to the FDA and other regulatory agenciesSupport the maintenance team when responding to high purity water systems and environmental monitoring alert/action notificationsSupport the investigation on all alert/action notificationsSupport the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of complianceAssist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programsEvaluate sanitization and maintenance proceduresPropose changes to the Department ManagerPropose modifications for process, utility and clean room systems to the Plant Engineering Group.
Competencies/SkillsLeadership and teambuildingVerbal communicationWritten Communication/Technical WritingOrganizationFacilitationDealing with and managing changeComprehensive understanding of validation protocol requirementsTechnical (Equipment Specific)Analytical Problem Solving Project Management & PlanningSchedulingComputer LiteracyRequirementsDoctorate degree or Master's degree and 3 years of Engineering experience or Bachelor's degree and 5 years of Engineering experience or Associate's degree and 10 years of Engineering experience or High school diploma / GED and 12 years of Engineering experiencePREFERRED QUALIFICATIONS: MAXIMO data entryData sheetsJob plansDrawings knowledgeBenefits6-MONTHS CONTRACT Administrative Shift
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