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 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.

Primary Responsibilities:

• 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 teams 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.

Education Minimum Requirement:

• Bachelors Degree in Engineering Science or related technical field

Required Experience and Skills:

• Minimum 8 years Maintenance or Engineering experience in regulated industries such as pharma biotech aerospace cGMP operations (6 Years with a masters 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.

Preferred Experience and Skills:

• Working Knowledge of cGMP for pharmaceutical Sterile and/or Biologics manufacturing

• SAP experience related to plant maintenance and spare parts procurement systems

• Reliability engineering experience

• Good oral and written communication skills

• Project management including change control and equipment qualification experience

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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