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Automation Engineer II

National Resilience

National Resilience

Software Engineering
Alachua, FL, USA
Posted on Wednesday, May 22, 2024

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

Resilience Government Services (RGS) is seeking an experienced Automation Engineer to lead and perform the design, development, installation, validation, and maintenance of Process Automation systems at its Biomanufacturing facility located in Alachua, Florida.

This role will ensure the successful operation of several types of Automation related equipment and systems including but not limited to PLCs, SCADA, HMIs, Servers, Databases, both on fixed and portable equipment, and will interface with multiple departments (e.g.: Engineering, Maintenance, Manufacturing, Digital, QA). Successful candidate will have advanced knowledge and experience developing and maintaining Process Automation systems and executing related Life-cycle management activities to support GMP manufacturing systems, facilities and critical infrastructure systems, and laboratory systems. The Senior Automation Engineer understands industry best practices and Regulatory requirements and ensures that automations system remain compliant to current GMP, Validation and Data Integrity requirements.

This position reports to the Manager of Engineering and will work very closely with Process, Equipment, Maintenance, Validation, Digital Quality, Digital, Quality Engineering and Manufacturing functions.

Job Responsibilities

  • Lead the design, development, installation, validation, set up and maintenance of Process and Building Automation Systems in a regulated GMP environment.
  • Mobilize and adapt automation systems for various manufacturing projects including connection of portable and fixed equipment to the Production Network, SCADA, Databases, and Historians for the purposes of collecting, archiving, retrieving, and trending process data and alarms.
  • Provide guidance and support to various user groups (e.g.: Manufacturing, Research, Validation, Quality Engineering) on the use of the automation systems to monitor and control processes.
  • Ensure that automation systems conform to all applicable regulations and industry standards, including GxP, Data Integrity, CFR Part 11, and Cyber Security requirements.
  • Support the implementation and adoption of standards, procedures, and metrics pertaining to Automation and Control Systems between Sites and within the broader company, including the generation of governing documents, System Architecture, Specifications, SOPs, URS, FRS, and VMPs.
  • Participate in audits and continuous improvement efforts related to process monitoring and control systems, including DI compliance and remediation.
  • Operate and maintain several types of automation equipment and systems including but not limited to PLCs, SCADA, HMIs, Servers, Databases, and other control system equipment.
  • Support the development, operation, and maintenance of Building Automation Systems.
  • Support the operation and maintenance of electrical equipment and power systems including but not limited to Switchgear, UPS, Back Up generator, Normal Electrical Power Distribution, and lighting systems.
  • Design, implement and manage automation tasks in Ignition, PI, REES, VAISALA, and similar systems.
  • Provide technical guidance and support for internal technicians and engineers, as well as support for contracted projects.
  • Contribute to the optimization and improvement of manufacturing processes, unit operations, critical utilities, and related automation infrastructure.
  • Develop SOPs, work instruction, test methods, requirement specifications and other documents.
  • Participate in the design, optimization, commissioning, or validation of newly procured or existing equipment as the automation/electrical lead.

Minimum Qualifications

  • Multiple years of direct experience performing and leading Automation responsibilities from well-established Biomanufacturing or Pharmaceutical facilities.
  • Experience in Building Automation Systems and various Electrical and Power Systems will be advantageous to this position.
  • Direct experience with biomanufacturing processes, unit operations and equipment and related Process automation systems supporting GMP manufacturing.
  • Through understanding of PLCs, SCADA, HMIs, Servers, Databases, and other control system equipment.
  • Thorough understanding of PI, REES, VAISALA, and similar systems.
  • Strong knowledge of FDA and cGMP regulations and documentation practices.
  • Strong knowledge of GAMP 5.
  • Strong knowledge of 21 CFR Part 11 and Annex 11.
  • Strong knowledge of computer system validation methodologies.
  • Understanding of modern and risk-based validation executions.

Desired Qualifications

  • At least 5 years of direct experience performing and leading Automation responsibilities from well-established Biomanufacturing or Pharmaceutical facilities.
  • Bachelor’s degree in engineering (e.g.: Automation & Control, Electrical, Computer, Process) or equivalent with 3+ years of relevant Process Automation experience preferably in the biotech / pharma industry.
  • MS degree in engineering or a related STEM field with 2+ years of Automation experience.
  • Experience implementing and managing Building Automation System, Electrical and Power Systems to support GMP manufacturing.
  • Experience with Automation equipment/system design, DI assessment, procurement, installation, qualification, CSV, and DI gap mitigation strategies.
  • Strong Computer system/process/control aptitude with an understanding of critical process parameters and control strategies.

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.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $70,000.00 - $100,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.