Maintenance and Calibration Lead

We areLOTTE BIOLOGICSDelivering Therapies That Enable a Healthier World.A new company, built on 80 years of tradition. We embody our core values of beingInspired by Science,Embracing Diversity,Fostering Talent, andConnecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.Position SummaryThe Maintenance and Calibration Lead is responsible for overseeing and coordinating maintenance and calibration documentation, compliance workflows, and continuous improvement initiatives that directly support the reliability and regulatory integrity of site operations. This role ensures that maintenance and calibration activities are effectively documented in compliance with regulatory requirements and company policies, and that continuous improvement opportunities are identified and implemented.A significant aspect of this role includes exercising independent judgment in reviewing technical documentation, recommending updates to job plans, asset records, and managing corrective actions in Maximo. The Lead acts as a liaison between Maintenance, Metrology, and Quality teams and ensures that work performed is audit-ready and aligns with operational priorities.While not a formal people manager, the Lead provides informal leadership, technical guidance, and mentorship to the team and serves as a point of contact in the absence of the supervisor. Additionally, this role provides dotted-line support to the Metrology Engineer, helping manage Out of Tolerance (OOT) investigations, vendor coordination, and standard documentation workflows—enabling the Metrology Engineer to focus on technical strategy and project support.Duties & ResponsibilitiesReview and analyze maintenance and calibration documentation within Maximo to ensure compliance with cGMP standards; initiate updates to job plans, asset records, and track corrective actions.Provide back-up support to the Metrology Engineer, including OOT process initiation, tracking, and vendor coordination.Conduct periodic audits of maintenance and calibration records for adherence to regulations, SOPs, and Good Documentation Practices; develop and deliver training to reinforce compliance and documentation quality.Use independent judgment to prioritize and coordinate maintenance and calibration documentation tasks based on operational risk, asset criticality, and compliance impact.Support cross-functional improvement initiatives to enhance maintenance and calibration reliability and minimize equipment downtime.Lead or contribute to root cause analysis and CAPA activities related to maintenance or calibration non-conformances.Serve as point of contact in the absence of the supervisor to ensure operational continuity and team support.Act as CMMS (Maximo) documentation SME, ensuring data integrity and supporting audit readiness.Conduct post-maintenance inspections with QA and Operations to verify completion, compliance, and readiness for production.Maintain strong communication and alignment with internal stakeholders including Quality, Safety, and Technical Services.Conduct safety and environmental walkthroughs to ensure adherence to site policies and regulatory requirements.Education & ExperienceAssociate's degree in a technical field or equivalent training required; Bachelor's degree in engineering or related field preferred.5+ years of experience in an industrial, maintenance, or operations support role.Certifications (e.g., ISA, ASQ, or similar) in calibration, maintenance, or reliability are desirable.Knowledge, Skills, AbilitiesProficiency in using CMMS (Maximo) for asset and work order management, job planning, and documentation workflows.Thorough knowledge of industrial equipment used in pharmaceutical manufacturing.Strong understanding of FDA, OSHA, and GMP regulations.Ability to interpret SOPs, technical drawings, and equipment manuals.Ability to assess and recommend spare parts strategies for reliability and maintainability.Demonstrated ability to exercise discretion and independent judgment on matters of compliance and documentation quality.Strong technical writing and documentation review skills.Familiarity with reliability-based maintenance (RBM) and asset lifecycle principles is a plus.Physical DemandsThis role requires a combination of office-based and manufacturing environment activities.Ability to sit or stand for extended periods while reviewing documentation, training staff, and performing compliance work.Ability to walk through manufacturing, maintenance, and laboratory areas to conduct audits, inspections, and walkthroughs.Occasional climbing of stairs, ladders, or elevated platforms during facility inspections.Ability to bend, stoop, kneel, and reach to visually inspect equipment, instrumentation, or work areas.Ability to lift and carry up to 25 pounds occasionally (e.g., calibration standards, files, or tools).Sufficient visual acuity to review technical documents, calibration data, and computerized systems.Ability to communicate effectively in person and via electronic means.Must be able to wear required Personal Protective Equipment (PPE), including but not limited to safety shoes, eye protection, hearing protection, lab coats, and respirators as needed.Work EnvironmentThis role is primarily office-based with routine oversight and presence in production, maintenance, and equipment areas. The position may require occasional work in cleanroom or controlled environments and around noise, chemicals, or elevated areas, with appropriate Personal Protective Equipment (PPE). The employee must be able to comply with site safety procedures, gowning requirements, and regulatory controls while performing job duties.Supervisory ResponsibilitiesThis position does not include formal direct supervisory responsibilities but provides informal leadership, mentorship, and operational guidance to maintenance and calibration team members. The Lead acts as a subject matter expert (SME), exercises independent judgment in asset management and compliance documentation, and supports coordination of maintenance and calibration workflows in the absence of the supervisor. The role also includes dotted-line support to the Metrology Engineer for standard documentation and vendor-related functions.Travel