Maintenance and Calibration Lead

We are LOTTE BIOLOGICS
! Delivering Therapies That Enable a Healthier World
.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science
, Embracing Diversity
, Fostering Talent
, and Connecting 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.

The 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.

• Review 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.

• Associate’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.

• Proficiency 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…