Associate Director, Engineering

Job Description

Our Engineers support complex manufacturing operations to ensure they are reliably executed and continuously improved. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

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 for the facility. This role is responsible to lead the tactical and strategic initiatives that will drive reliability improvements. In addition, this role provides leadership that ensures a safe work environment with optimized product quality and manufacturing processes and regulatory compliance.

The facility consists of biotech operations including end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, and product inspection.

• Provides leadership and direction through individual contributors in the team, including contractors and full time employees.

• Develops team strategy, including reliability plan, routine maintenance and improvement work, and executes to functional business plans.

• Prioritizes based on compliance, reliability, departmental budget and production plan to address resource and operational challenges.

• Leverages relationships with key clients and/or customers to support business needs.

• Coaches/mentors direct reports responsible for their area.

• Ensure proper team capabilities with appropriate trainings.

• Manage the area succession plan across diverse skillsets for roles within team.

• Partner across the facility leadership team and cross-functional teams (local and global) including for the startup and design of plant engineering, reliability, and maintenance programs for the facility.

• Team responsibilities for improvement and maintenance projects may include change control and equipment qualification, obtaining bids, reviewing contracts, supervising, and providing follows-up on contract work within team’s scope, including the auditing of time and material reports for their area.

• Responsible for assisting with master shutdown schedules and shutdown execution including all maintenance, calibration, capital project work, and GMP cleaning coordination for all facility shutdowns.

• Responsible for regular maintenance shutdowns including project leadership and meeting facilitation.

• Responsible for the preventive maintenance and calibration programs of all production equipment.

• Daily support of all production equipment to ensure area safety, compliance, and production goals are met.

• Spare parts risk‑based assessments and identification of new parts to replace obsolescent parts to ensure correct type and number of spare parts are available for all production equipment.

• Establishes processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities.

• Manages equipment location and status in SAP as well as related equipment drawings.

• Assists in deviation investigations for maintenance instruments, equipment, and systems.

• Collaborates/ Executes with the reliability engineers periodic reliability‑based asset management assessments and owns area specific reliability actions.

• Collaborates with production and automation for maintenance and troubleshooting equipment.

• Collaborates with equipment vendors.

• Monitors calibration, maintenance, and equipment/utilities operations performance by analyzing completed work orders with an emphasis on reducing reactive work and increasing reliability.

• Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.

• Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures.

• Monitor KPIs (MTTR, MTBF, Uptime) and ensure its accuracy in measuring key metrics.

• Interacts and leads discussions within scope of work with representatives from regulatory agencies and external supplier.

• Bachelor’s Degree in Engineering, Science or related technical field

• Minimum 8 years Maintenance or Engineering experience in regulated industries such as pharma, biotech, aerospace, cGMP operations (6 Years with a master’s degree or MBA: 4 years with a PhD), or military service combined experience:
• Working knowledge regulatory requirements in accordance with cGMP manufacturing operations and demonstrated experience of interacting with site, divisional or regulatory audits/inspections.

• Working Knowledge of cGMP for…