A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary & Role

The Manager of Engineering reports directly to the Director of Engineering and Technology. The selected person will be responsible for managing and performance of direct reports across own organization, managing sub-functions (including process engineering, automation engineering, electrical engineering, facility engineering, equipment engineering and capex engineering), managing resources, budgets, projects, and communication with the customers / auditors. In addition, this position will work with senior leadership members, other managers, supervisors, engineers and technicians to prioritize and plan work according to facility requirements.

Job Responsibilities

• Lead a group of engineers to execute projects, support manufacturing operations, implement capital projects, and optimize systems/processes in the areas of process engineering, automation engineering, electrical engineering, facility engineering, equipment engineering and capex engineering functions.
• Examples of systems/functions being managed by this position include the following:
  • Clean Utilities - USP high purity water, water for injection, clean steam, clean compressed air, lab, and manufacturing gas systems
  • Automation - building automation system (BAS), SCADA, alarm monitoring system (AMS), autoclaves and sterilizers, area decontamination system.
  • Manufacturing Equipment- Upstream and Downstream biomanufacturing equipment, Single use systems, Analytical systems
  • Facility Systems - HVAC, Decontamination systems, Sterilizers, Neutralization systems, Boilers, Chillers
  • Electrical Systems- Multi-feed plant electrical systems, ATS, UPS, Generators
• Develop and execute plans to meet manufacturing, quality, compliance, and EHS goals/metrics.
• Hire, train, mentor and develop best in class engineers and develop a high-performance team.
• Implement resource, time, or money saving projects for the site
• Provide high-level administrative and technical guidance for internal engineers, technicians, as well as engineering oversight for contracted projects.
• Lead, or assist, in the expansion / fit out projects in terms of construction, resource planning, resource assignments, budget, and schedule.
• Contribute to the generation and execution of engineering and validation documents including URS, FRS, protocols, and reports.
• Support facility commissioning and validation efforts.
• Contribute to optimization and improvements of CGMP products, systems and processes.
• Write or approve SOPs, work instructions, test methods, requirement specs and other documents required to standardize and maintain processes managed by ENGR organization.
• Lead or assist in out-of-specification deviation, CAPA, Change Control, ECM, other quality management system documentation.
• Lead efforts to develop cross-functional partnership with Manufacturing, Process Development, Quality Control, Quality Assurance, and other internal customer departments.
• Maintain statistical analysis of process and utility data.
• Collecting and reporting of KPIs.
• Developing goals of direct reports in alignment with department and corporate goals.
• Compile information for preparation of an annual budget.
• Propose and manage operational budget within the scope defined by supervisor.
• Support and help to maintain communication with key customers (DoD, commercial clients etc.) within the range defined by supervisor.
• Directly participate on internal / external audits utilizing own reports and resources.
• Manage, task, coordinate and organize all direct reports.
• Regularly inspect, check, and assess quality of the work/services provided by ENGR organization.
• Propose and implement improvements to save/optimize resources. Track and maintain compliance with internal and external requirements.
• Support business project implementations in the scope defined by supervisor.
• Support preventive and corrective maintenance processes inclusive of annual full facility shutdown.
• Maintain technical documentation such as specifications, ETOPs, manufacturer manuals, technical drawings, P&IDs, etc.
• All other tasks as needed or assigned by supervisor.

Minimum Qualifications

• Extensive experience in biomanufacturing or pharmaceutical facilities
• Previous experience in formal management of direct reports
• Experience with optimizing process systems.
• Experience working in a regulated GMP environment.
• Strong leadership, technical, communication, and organization skills in a cross-functional teamwork environment.

Preferred Qualifications:

• MS degree in engineering, or a related STEM field with four years of experience
• Experience in Engineering management experience from Biomanufacturing or Pharmaceutical facilities
• Experience with equipment/process design, procurement, installation, and qualification.
• Strong mechanical/electrical/process aptitude with an understanding of critical systems.

Role/Site Specific Requirements

This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.

Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.

Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing)

Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.)

Exposure to the following:

• Moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals.
• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Close quarters, narrow passageways, crawl spaces, shafts, manholes, small enclosed rooms, small sewage and line pipes.
• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
• Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.