Associate Director, Engineering

Job Overview

The Associate Director, Engineering is responsible for the maintenance and reliability of both utilities and process equipment. The scope of responsibilities includes maintenance and calibration, management of spare parts, and facility services. This role leads tactical and strategic initiatives for reliability improvements, ensures a safe work environment, and optimizes product quality and manufacturing processes in compliance with regulations. The facility includes biotech operations for drug substance and product, culture growth, harvest, lyophilization, and inspection.

• Provide leadership and direction to individual contributors, contractors, and full-time employees.
• Develop team strategy including reliability plan, routine maintenance and improvement work, and execute against functional business plans.
• Prioritize based on compliance, reliability, departmental budget and production plan to address resource and operational challenges.
• Leverage relationships with key clients and customers to support business needs.
• Coach and mentor direct reports and ensures proper team capabilities with appropriate trainings.
• Manage area succession plan across diverse skillsets within team.
• Partner across the facility leadership team and cross‑functional teams, including local and global, to design plant engineering, reliability, and maintenance programs.
• Oversee improvement and maintenance projects, including change control, equipment qualification, obtaining bids, reviewing contracts, supervising contract work, and auditing time and material reports.
• Assist with master shutdown schedules and shutdown execution, coordinating maintenance, calibration, capital project work, and GMP cleaning.
• Lead regular maintenance shutdowns, project leadership, and meeting facilitation.
• Maintain preventive maintenance and calibration programs for all production equipment.
• Provide daily support of all production equipment to ensure safety, compliance, and production goals.
• Conduct spare parts risk‑based assessments and identify new parts to replace obsolescent parts.
• Establish and enforce safety guidelines and participate in divisional Safety Audit activities.
• Manage equipment location and status in SAP and related equipment drawings.
• Assist in deviation investigations for maintenance instruments, equipment, and systems.
• Collaborate with reliability engineers on periodic reliability‑based asset management assessments and own area‑specific reliability actions.
• Collaborate with production and automation for maintenance and troubleshooting equipment.
• Collaborate with equipment vendors.
• Monitor calibration, maintenance, and utilities operations performance, analyze completed work orders to reduce reactive work and increase reliability.
• Maintain integrity of equipment identification and specification data in the calibration and maintenance management system.
• Identify revisions, deletions, or additions to calibration and maintenance programs.
• Monitor KPIs (MTTR, MTBF, Uptime) and ensure accurate measurement.
• Interact and lead discussions with regulatory agencies and external suppliers.

Minimum Requirement: Bachelor’s Degree in Engineering, Science, or a related technical field.

• Minimum 8 years of maintenance or engineering experience in regulated industries such as pharma, biotech, aerospace, cGMP operations.
• Working knowledge of regulatory requirements in accordance with cGMP manufacturing operations.
• Experience interacting with site, divisional or regulatory audits/inspections.
• Working knowledge of cGMP for pharmaceutical, sterile, and/or biologics manufacturing.
• Experience with SAP related to plant maintenance and spare parts procurement systems.
• Reliability engineering experience.
• API manufacturing, calibration of equipment, capital projects, change control systems, chemical process development, cross‑cultural awareness, cross‑functional teamwork, equipment qualification, general safety, global manufacturing, GMP compliance, maintenance management, maintenance processes, manufacturing process validation, people leadership, plant maintenance, preventive maintenance, process optimization,…