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Director, Engineering & Technology

Employer
Resilience
Location
Alachua, FL
Start date
May 11, 2022

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Job Details

General Company Description

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.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 and Job Responsibilities

Reporting to the Site GM, the Director of Engineering and Technology will be a member of the Site Leadership Team.

The individual will be responsible for the facilities Alachua Campus which includes all utilities, GMP facilities, offices, warehousing, laboratory and process development areas and associated structures.

Within the scope of this role are the site internal PMO (Project Management Office) governing CapEx planning, Project Management, Reporting and Controls, Facilities, Utilities, Housekeeping, Maintenance, Metrology, Engineering, Validation (EMPQ, IQ, OQ, PQ, FAT and SAT activities) and Engineering Documentation / Drawing Management. The position is responsible for maintaining and improving the facilities and keeping them at all times in top shape, audit ready and GMP compliant.

The individual will be responsible for planning, identifying, assessing, developing, and deploying manufacturing process technology on the site to ensure site capability matches customer demand and modalities (i.e. Biologics, Vaccines, Viral Vectors) in close cooperation with the Franchise Leaders and Supply Chain Demand Planning for DS and DP manufacturing. This includes the Site CapEx portfolio development across the site functions, subsequent prioritization, monitoring and ensuring the delivery of projects to Operational Readiness in collaboration with the site functions.

Under the individuals leadership, The internal site PMO will coordinate the execution of projects in collaboration with project managers across all site and network Technical Operations functions (Manufacturing, MS&T, Quality, Supply Chain), other manufacturing sites and with Franchise Leadership, Business Development, Process Development, and Digital.

Provide direct oversight of the fulfillment of the following specific responsibilities:

  • Ensure the utilities, equipment, controls, and communication systems are maintained in full compliance with all relevant safety, environmental, cGMP requirements, and corporate standards.
  • Develop the instruction set (procedures and performance criteria) relating to procuring, qualification, maintenance, and repair of utilities, equipment, control, and communication systems.
  • Develop and maintain the site capital LRP (Life Cycle Management) in collaboration with the CapEx function. This includes disposal of surplus or obsolete and unused assets.
  • Ensure appropriate maintenance, cleanliness and state of qualification is maintained for utilities, equipment and facilities.
  • Deliver on budget commitments and champion Continuous Improvement opportunities in concert with the Operational Excellence objectives for the Site. Oversee the development and management of predictive, preventive, and reliability-based maintenance programs.
  • Oversee the maintenance and modification of computerized process control systems and maintenance/calibration management systems.
  • Ensure all personnel, including contractors, consultants, and temporary employees who work in the department and directly or indirectly support a cGMP activity, have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
  • Ensure individual training/learning plans are kept current and that employees complete, and document all required initial and continuing learning.

S/he will be asked to perform/lead other key initiatives and activities within the site, as assigned.

Qualifications

  • Bachelor's degree in an Engineering or Life Sciences discipline with 12-15 years of progressive engineering experience in Biologics or Pharmaceutical industries, or master’s degree in an Engineering or Life Sciences discipline with 10-12 years of progressive engineering experience in Biologics or Pharmaceutical industries.
  • 5-8 years of management experience. Biologics/Pharmaceutical facility startup experience.
  • In-depth knowledge of Biotechnology processes, concepts, techniques, and engineering principles.
  • Sound understanding of integrated commissioning and qualification practices.
  • Working knowledge of cGMP requirements within a regulated environment.
  • Excellent communication skills - verbal, written, listening and interpersonal.
  • In-depth knowledge of cGMP/cGLP requirements in a regulated environment.
  • Solid understanding of Health, Safety, Environmental and Legal requirements for operations
  • Good understanding of managing large, complex facilities and engineering operations.
  • Excellent people leadership and change leadership skills. Demonstrated ability to develop self; build high performance teams, develop others.
  • Excellent communication skills and ability to influence and build relationships across the broadest constituencies both internal and external to the site.
  • Excellent problem solver and able to generate innovative solutions to broad range of issues.
  • Experience facilitating process optimization and process change initiatives in a cross-functional setting.
  • Experience working cross-functionally and cross-culturally in the development of business processes and/or systems, especially as they impact and influence multiple departments and levels of management.
  • Excellent program and project management skills
  • Experience negotiating supply agreements, technical services, and related contracts.
  • Very strong and highly effective strategic thinker and problem solver with high degree of emotional intelligence, with the ability to both recognize and anticipate problems.
  • Demonstrated ability to translate solutions into viable action plans at a global level that are effectively disseminated and implemented through cooperation of stakeholders.
  • Demonstrated ability to effectively build business relationships and influence in a matrix organization.
  • Proactive self-starter with confidence and ability to identify new areas for continuous improvement, bring stakeholders together and develop and execute plans that drive positive change.

Preferred Experience

  • Master’s Degree (or equivalent) in Life Sciences/Engineering/Business, required. MBA or Legal experience preferred.
  • 15+ years in the healthcare industry with specific experience in BioPharma/Pharma and cGMP manufacturing
  • Knowledge of biotechnology processes/concepts/techniques and engineering principles.
  • Technical knowledge of biologics manufacturing systems and processes.
  • Knowledge of statutory inspection requirements.
  • You have a significant number of years’ experience in Manufacturing, Supply Chain, Quality, MSAT, Project Management or related disciplines and previous experience in strategy building for a technical operation organization

Physical Requirements:

This job requires the employee to perform the following physical activities:

  • Climbing
  • Balancing
  • Fingering
  • Stooping
  • Kneeling
  • Crouching
  • Feeling
  • Reaching
  • Standing
  • Grasping
  • Walking
  • Pushing
  • Hearing
  • Pulling
  • Lifting
  • Talking

This job requires the employee to work in the following conditions:

  • Temperature changes
  • Activities occur inside and outside
  • Temperatures above 100 degrees Fahrenheit for periods of more than one hour
  • Outside environment conditions

This job requires exposure to the following:

  • Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
  • Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.

This job requires the following visual acuity requirements:

  • Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

This job requires routine or periodic use of respiratory protection:

  • Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).

Equal Opportunity Statement

At Resilience we believe that the business of business is to improve the state of our world. We are committed to creating a workforce that reflects society, to maintaining inclusive programs and to providing equal opportunities to qualified individuals.

Resilienceis 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 protected by applicable law. Applicants who require reasonable accommodations for any portion of the job application process may contact careers@resilience.comfor 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 withResilience.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

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