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Automation Systems Engineer

2 months ago

Tampa, Florida, United States BioSpace, Inc. Full time
Job Summary

We are seeking an experienced Automation Engineer to lead and perform the design, development, installation, validation, and maintenance of Process Automation systems at our Biomanufacturing facility located in Alachua, Florida.

Key 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 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.
Requirements
  • 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.
Preferred 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.
Work Environment

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.

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).