Our client, a leading pharmaceutical company, is hiring an Automation Controls Engineer on a contract basis.
Automation Engineer supports the successful operation of Automation system, peripheral devices and lab equipment at Bothell CTF. This role will lead projects and collaborate with external service provides to maintain system performance and up-time. The individual manages IT projects, system upgrades and ongoing work activities of moderate to high complexity in nature.
Reporting into the IT organization the candidate will be primarily responsible for driving solutions to automation system related problems including reviewing, planning, building, testing, documenting, and implementing design changes. The candidate should have at least 2 years of experience in pharma/biotech & Good Manufacturing Practices (GMPs) environment. In addition, preferably have prior experience in Distributed Control System (DCS) implementation preferably Emerson DeltaV, OSIsoft PI Historian implementation, automation system infrastructure, Manufacturing Execution System (MES) system integrations preferably Emerson Syncade.
Education: • Bachelors degree in Engineering, IT, Science field or equivalent experience
Experience • 2 years relevant industry experience. Preferably in pharmaceutical/ Life Sciences industry.
• Demonstrated expertise in IT/Automation infrastructure and Process
Automation Systems preferably DeltaV.
• Experience with control system networking technologies, PC networking technology and virtualization.
• Experience in developing/executing validation protocols.
• Experience with life cycle management of automation systems; patch
scheduling, and infrastructure maintenance.
• Expert understanding of S88, S95 and batch processing operations required.
• Understanding of engineering documentation such as P&IDs, process flow
diagrams and standard operating procedures.
• Ability to troubleshoot control systems from the field element up through
operator interfaces and databases.
• Experience with DeltaV Backup & Recovery preferred but not required.
• Experience implementing, maintaining and/or interfacing with Data Historians
(OSIsoft PI system) and relational databases (SQL) preferred but not
• Sound understanding of Electronic Batch Records (EBR) and Review by
• Experience with business process re-engineering, including documenting
workflows and developing functional specifications.
• Experience managing schedule and resources.
Knowledge, Skills, and Abilities
• Ability to effectively communicate with both technical and non-technical team
• Strong interpersonal skills, especially regarding Teamwork and collaboration.
• Excellent communication skills including oral, written, and formal presentations.
• Ability to create and document Technical Architecture.
• Strong technical and problem-solving skills and the ability to work independently.
• Knowledge of Cell Therapy Facility (CTF) IT Architecture and IT Infrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, Hyper-V, Virtualization etc.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Knowledge of Cybersecurity, patching and IT Life Cycle Management (LCM).
• Knowledge of DeltaV system upgrade and procedures.
• Understanding of computer system validation.
• Knowledge of industry standard integration protocols and programming applications such as OPC UA, Ethernet IP, Web API.
• Familiarity with Business Intelligence (BI) and reporting programs including InfoBatch or similar tools.
DUTIES AND RESPONSIBILITIES:
This role will lead projects composed of indirect reports as well as contractors to deliver effective, innovative, and stable solutions that meet the needs of the facility.
Key Responsibilities include:
• Act as support member for Bothell Cell Therapy Facility Process Automation Systems, data collection (OSI PI) and analytics deliverables.
o Delivering the requirements for the Process Automation Systems (DeltaV) infrastructure as well as the Unit operations within the Process automation system.
o Integration needs with the Manufacturing Execution System (Syncade) & Data
Historian (OSI PI)
• Help set the PAS priorities for the Bothell CTF and co-ordinate the delivery of these priorities.
• Help develop PAS standards, philosophy, design approach and SOPs for Bothell CTF.
• Will work with the site PAS team and the business to develop Business continuity plan for Bothell CTF PAS application.
• Will drive and support the resolution of critical PAS issues.
• Provide leadership for lifecycle management of IT control systems, system updates, patch scheduling.
• Will coach and mentor PAS engineers on CTF requirements and deliverables.
• Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy the DCS and Historian systems and MES integration.
• Accountable for uninterrupted 24/7 operation of automation system and lab equipment for CAR T manufacturing.
• Manage daily operation and future enhancements of Automation system and lower-level systems as an IT system owner and technical expert.