- Requirements Gathering
- Visual Basic
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I: Job Summary
The Automation Engineer will be responsible for supporting automation and control systems at the Emergent Biosolutions Bayview Manufacturing site. This will include supporting the long-term strategic development goals for the site automation systems, ensuring compliant operation of all validated control systems, as well as supporting day-to-day trouble-shooting and problem-solving activities associated with existing enterprise and equipment-based control systems.
This role will also support multiple projects of varying complexity and size which will include outside control system integrators, technicians, IT infrastructure, manufacturing personnel, validation personnel, and quality control/quality assurance.
Work independently as well as within multidisciplinary teams to provide routine support of site manufacturing and facility operations, specifically relating to control, automation, and instrumentation systems.
Troubleshoot and provide corrective actions for existing manufacturing and facility control system, automation, and instrumentation.
Provide 24/7 on-call support on a rotation-based schedule.
Support the preparation and review of engineering standards, PMs, SOPs, commissioning protocols, user requirement specifications, acceptance test plans, IQ/OQs, Functional Specifications, Design Specifications, and drawings and diagrams
May be responsible for leading teams as well as functioning is supporting role for team efforts.
Work with site Quality and Computer System Validation experts to ensure automation and control system GMP compliance.
Support the implementation and completion of change controls, CAPAs, and Deviations for automated GMP systems and equipment.
Proactively search for and implement innovative solutions to improve site automation performance, reliability and compliance.
Support training efforts for new equipment installations
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
Bachelor’s degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines
5+ years’ experience supporting or developing automated systems.
Proven programming experience with Allen-Bradley/Rockwell PLCs and Rockwell Software applications, including FactoryTalk SE/ME, RSLogix 500, RSLogix 5000, Studio 5000, etc.
Knowledge of Building Management/Automation Systems, preferably Siemens.
Knowledge of various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, and/or Profibus.
Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
Works well in a multi-discipline team structure.
Has strong communication and computer skills
Demonstrates skills in requirements gathering, design, configuration, integration, and implementation of process control solutions for the manufacturing industry including batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, Visual Basic and PC networking technology
Advanced training in process controls engineering.
Member of ISPE, ISA, or IEEE
Working experience with data management software, including OSIsoft Pi Historian, SQL databases, Crystal Reports, etc.
Familiar with pharmaceutical industry guidelines such as ISPE Baseline Guidelines, GAMP, ISO, and ISA Standards
Experience in pharmaceutical, biopharmaceutical, or consumer manufacturing
Knowledge of CAD software and equipment
Working knowledge of SAP
Familiarity with FDA cGMP and FDA regulations relating to biologic and drug products
Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11.
IV: Physical/Mental Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, and lift/carry 15lbs. Use phone, fax, copier, computer, copier and hand tools. Work outdoors, noise above conversation level, hot/cold temperatures, high humidity and restricted access laboratory. Organize/coordinate, analyze/interpret, problem-solve, make decisions, supervise, plan, communicate, prepare written communications and prepare transaction documents.