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Process and Critical Systems Engineer II - IV (Relocation Assistance)

Employer
Resilience
Location
Alachua, FL
Start date
May 8, 2022

View more

Discipline
Engineering, Manufacturing & Production, Process
Required Education
Bachelors Degree
Position Type
Full time

Job Details

General Company Description (Relocation Assistance)

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.

RESILIENCE (National Resilience, Inc.), is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans

For more information, visit www.resilience.com.

Position Summary & Role (general description of the role, e.g. expectations, key milestones, impact)

The Process & Critical Systems Engineer should be a GMP oriented individual with experience in cleanroom operation, process equipment (Autoclaves, bioreactors, chromatography skids etc.…), and utility systems operation, maintenance, and design, working in a cleanroom environment, and have a background of working in a regulated industry such as pharmaceutical.

Job Responsibilities (core responsibilities; include people management if applicable)

  • Member of facility response team and Responsible system engineer (RSE)
  • Seek for fir time or money saving efforts in process or utility systems
  • Responsible for generating room equipment layout and utility assessment for Projects
  • Technical lead for any issues which may arise in the cleanroom infrastructure and utilities
  • Responsible system engineer for process waste systems (Waste Neutralization, EDS, Room Decontamination)
  • Owner of Equipment Relocation Process
  • Responsible for tracking and update equipment status
  • Perform process equipment life cycle analysis
  • Establish process equipment and cleanroom infrastructure preventive maintenance activities
  • Assist other system owners in complex and cross-functional problem solving
  • Serves as Subject Matter Expert (SME) to support assigned work orders and Quality Systems. Support deviation investigations, root cause analysis, and CAPA identification and implementation
  • Lead optimization and improvements to cleanroom operations
  • Develop SOPS, work instruction, test methods, requirement specs and other documents
  • Heavy lifting and working in uncomfortable conditions (hot, wet, tight areas), as well as after hour and weekend work possible, but not typical
  • Heavy cross-functional dynamic teamwork support for Manufacturing, Quality, Assurance, R&D, and other departments as needed
  • Lead Statistical analysis of process and utility data through use of Building Automation
  • All other tasks as needed or assigned by supervisor
  • High technical ability with a troubleshooting approach
  • Provide technical assistance to management team
  • Systems which this person will interact and support as Mechanical Engineer will include but are not limited to:
  • Plant Utilities: domestic water, lab water, soft water, boilers, chillers, air compressors, air handling units, electrical systems, fuel, and natural gas
  • 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 (REES0(Vaisala)

  • Process Equipment: Autoclaves, bioreactors, chromatography skids etc..

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

  • Bachelor’s degree in engineering, computer science, or a related STEM or technical field (preferred) from and Accredited University.
  • Level II B.S and 3 - 5years’, or A.S and 5 – 7 years of experience in process equipment and cleanrooms in pharmaceutical environment
  • Level III BS and 5 - 7 years’, or A.S and 7 – 9 years’ experience in process equipment and cleanrooms in pharmaceutical environment
  • Level IV BS and 7+ years’, or A.S and 9+ years’ experience in process equipment and cleanrooms in pharmaceutical environment

Physical Requirements: (rows or statements that are not required to perform the duties of the position)

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

  • Climbing
  • Balancing
  • Fingering
  • Stooping
  • Kneeling
  • Repetitive motion
  • Crouching
  • Crawling
  • 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 for periods of more than one hour
  • Outside environmental conditions
  • Temperatures typically below 32 degrees for more than one hour

This job requires exposure to the following:

  • Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
  • Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
  • Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
  • Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
  • Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
  • Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
  • Close quarters, crawl spaces, shafts, man holes, small enclosed rooms, small sewage and line pipes.
  • Physical vibration.
  • Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
  • Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

  • Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
  • Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
  • Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
  • Heavy work. Exerting up to 100 pounds of force occasionally, and/or up to 50 pounds of force frequently, and/or up to 20 pounds of force constantly to move objects.
  • Very heavy work. Exerting in excess of 100 pounds of force occasionally, and/or in excess of 50 pounds of force frequently, and/or in excess of 20 pounds of force constantly to move objects.

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.
  • operates machines, such as lathes, drill presses, power saws, and mills where the seeing job is at or within arm's reach; performs mechanical or skilled trades tasks of a non-repetitive nature, such as carpenter, technicians, service people, plumbers, painters, mechanics, etc.
  • operates motor vehicles and/or heavy equipment.
  • determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

This job requires routine or periodic use of respiratory protection:

  • Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).
  • Tight-fitting respirators, such as half-masks or full facepieces which must seal to the face or neck.

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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