Director, Site Engineering & Facilities

Resilience.com

Boston, MA, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 04/05/2021
  • Website: resilience.com
  • Company Address:

About Resilience.com

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.

Job Description

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

Role

  • Reporting to the Vice President of Engineering, the Director of Engineering and Facilities will be a member of the Engineering Leadership team.
  • The Director of Engineering and Facilities will ensure facilities, utilities, and equipment are designed, fabricated, installed, and maintained compliant with the latest regulations while meeting safety, quality, productivity, operability, reliability, timeliness, and cost drivers.
  • The role represents critical infrastructure and process systems to internal leadership, auditors, partners, and project teams, while working closely with other technical functions, consultants, and contractors to achieve validation and environmental permit status required for initial and continued operation.
  • The incumbent will build, lead and motivate a high functioning team to achieve local/site operational success, and deliver on overall Resilience site objectives.

 

Job Responsibilities

  • Staff, train, coach, and develop engineers and technicians, providing regular performance feedback while ensuring a culture of quality, safety, inclusion, and diversity.
  • Serve as system owner for all cGMP and non-GMP utility systems.
  • Responsible for establishing installation readiness and maintenance of process equipment in support of manufacturing.
  • Provide technical, compliance, and performance oversight of the utility systems serving the manufacturing environment and support facilities, while establishing system performance trends and metrics.
  • Implement standards and framework for continuous improvement in quality, safety, operational readiness, and energy efficiency for systems, infrastructure, and operations, including metrics and reporting methods.
  • Lead and support technical investigations, CAPAs, and change controls, supporting the environmental health & safety (EHS) and quality assurance (QA) teams to ensure compliance with all government regulations, site standards, and programs.
  • Act as a technical expert to train and coach engineers and technicians on GMP construction installation, qualification, and preventive/corrective maintenance methods and procedures.
  • Accountable for technical systems documentation (P&IDs, URS, FS, FAT/SAT, Commissioning, IOQs, SOPs, datasheets, material and equipment specifications, etc.)
  • Drive design and establish the utilities and equipment planned maintenance (PM) program, utilizing appropriate computerized maintenance management systems (CMMS) data to plan, execute correctly, and document system maintenance for operational readiness.
  • Drive the development and implementation of Engineering Document control and the CAD drawing management program.
  • Deliver safe, compliant, and reliable calibration and maintenance services on all facilities and utilities.
  • Interact regularly with Resilience senior management to provide data-rich and relevant feedback on-site activities and personnel while serving as a conduit to relay information/objectives/changes to team members in a reliable and approachable manner.
  • Confirm all relevant external service providers meet vendor qualification requirements and perform according to contractual expectations and regulations in collaboration with QA and legal. Ensure effective monitoring and oversight of all contracted activities impacting facilities, utilities, and equipment.
  • Ensure constant readiness to represent departmental programs and activities to auditors and drive corrective action when identified or assigned.
  • Research, assess, and implement best practices for solutions provided during construction, installation, qualification, and operations and maintenance of the local site, contributing to the development of network-wide best practices and relevant support documentation.
  • Lead the implementation of technologies and programs for continuous improvement and sustainability.
  • May perform hands-on activities supporting site build and operations, ranging from equipment/systems setup, inspection, and maintenance support.

 

Qualifications

  • Demonstrated track record of leadership resulting in the successful delivery of large biotechnology capital, validation, and plant startup projects.
  • 15-20 years of leadership experience and ideally 8-10 years’ experience managing projects in biotech or pharmaceutical industry
  • Experience in executing LEAN Project Management techniques and familiar with the Lean Construction Institute
  • Works independently and fully accountable to deliver objectives with minimal direction
  • Experience in providing formal presentations as well as proven problem-solving skills
  • Adept at working in a fast-paced environment with competing priorities and ambiguity
  • Consistently works with and brings clarity to abstract ideas or situations across functional areas of the business
  • Ability to anticipate and solve problems
  • Proven ability to lead project teams without direct reporting authority
  • Sound knowledge of cGMP processing and current practices
  • Excellent written and verbal communications and presentation skills
  • Excellent organizational skills

 

Preferred Experience

  • Bachelor’s degree or higher in Life or Chemical Sciences, Pharmaceutical Sciences, an engineering discipline, or similar technical field.   Master of Business Administration preferred.
  • Project Management Professional (PMP) or other relevant certification preferred.
  • LEAN practitioner with one or more certifications (e.g., Scrum master, black belt, etc.) preferred

 

 

COVID 19 Alert – Resilience is closely monitoring the Coronavirus Disease (COVID-19). With a focus on candidate and employee safety, we have implemented a temporary process change shifting all in person interviews to be conducted virtually until further notice. 

Equal Opportunity Statement

At Resilience, we believe that the business of business is to improve the state of our world. Each of us has a responsibility to drive Equality in our communities and workplaces. We are committed to creating a workforce that reflects society through inclusive programs and initiatives such as equal pay, inclusive benefits, and more. 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.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. Resilience welcomes all.

Resilience does not accept unsolicited headhunter and agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.