About us Your Contribution Possess knowledge and capabilities to execute Maintenance/Facilities Technician (all levels) roles and responsibilitiesMonitor daily work orders and employee activitiesCoordinate with various department stakeholders on Maintenance actionsHelp minimize machine downtimeLead, coach and train Maintenance TechniciansProcure parts, materials and resources to increase machine uptime; impart expertise and techniques to others within the departmentEstablish shift schedules to meet business needs; manage employee schedulesActively lead and participate in projects/events to drive improvementsFill in for the Maintenance Manager, as neededHelp with achieving department deliverables and initiatives Participate in the interviewing/hiring processHost meetings accordinglyEnsure clean and safe workspacesMaintain attendance within the payroll systemFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, required / Vocational school degree, preferredMinimum (3) years of maintenance/facilities experience in leading and directing the work of others in a fast-paced manufacturing settingStrong mechanical aptitudeUnderstanding of ISO and cGMPAbility to foster and follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachService orientedRobust communication skills and openness to learn/developWork a fixes 8-hour shift schedule Monday to Friday, but some weekend/night work, as neededUp to 5% travel, if needed to satisfy business demand Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
Lead and continuously improve the GMP self-inspection program, including annual planning and execution Coach SMEs and audit teams to ensure strong inspection and self-inspection readiness Perform gap assessments on global procedures and drive alignment across site functions Coordinate cross-functional activities and ensure effective communication with all departments Support internal, external, and mock audit preparation, including document review and QA input Act as backroom/ACC or scribe team member during audits and inspections Serve as Data Integrity Champion and ensure consistent DI implementation across the site Prepare and present compliance topics to the Quality Council and site leadership Support continuous improvement initiatives and coordinate operational activities within the compliance team Act as back-up for the Quality Compliance & Systems Expert when required University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical discipline Solid experience in biotechnology and/or pharmaceutical industry Strong knowledge of GMP requirements and Quality Systems Understanding of manufacturing, QC laboratory, and warehouse processes for biological products Solid knowledge of Good Documentation Practices (GDDP) and Data Integrity principles Experience supporting audits and regulatory inspections Skilled in writing, reviewing, and updating SOPs and technical documentation Familiarity with risk management tools (FMEA, RCA, etc.)