Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug and device development through post-approval. Synterex is seeking an organized, motivated, and collaborative individual for our Safety Surveillance Associate.

As an Automation Engineer you will support equipment automation, information collection and reporting, and manufacturing workflow solutions. Participates in the design, deployment, integration, maintenance, and validation for all site automation and related systems, data acquisition systems, recipe management, and electronic work instruction systems. Major systems include distributed control, assorted programmable logic controllers, process data archive, batching systems, industrial SQL, and recipe control. Supports manufacturing, safety, quality, and environmental projects and requirements to include all capital expansions in addition to daily optimization of manufacturing and business processes. Experience in automation network hardware and protocols e.g., MODBUS/TCP, Device Net, Ethernet/IP, etc. is desired.

Contract length: 12 months

Location: 100% Onsite Hybrid Role – Middleton, WI

Must follow return to site policy

Essential Duties & Responsibilities:

• Performs task to execute controls/automation-related tasks (code review and investigation, code development and change control execution) and support execution of equipment qualifications.
• Monitors and maintains automated system functionality. Prepares periodic evaluation reports for automated systems used in commercial manufacturing.
• Implements PLC and HMI software application changes and upgrades for automated process equipment.
• Supports Validation Department with initial design review, software testing, and protocol review related to automated systems.
• Communicates with engineers on potential improvements.
• Generate and evaluate data from equipment operation to determine if it meets performance requirements. Provide recommendation(s) to enhance equipment performance as needed.
• Perform periodic system and security reviews of automation systems and applications.
• Aids Engineering in the development and execution of Risk Assessments and Disaster Recovery procedures for automation systems and applications.
• Develop, standardize, and maintain Engineering Job-Aids, Standard Operating Procedures (SOPs), Guidelines, Functional Specifications, etc.
• Create and maintain engineering documentation with current Good Documentation Practices (cGDP).
• Assist with implementing Industrial Control Systems (ICS) Cyber-Security guidance and policies.
• Operate CAD software to design, draw or update components, parts, equipment, etc.
• Provides technical expertise and support to ensure the success of the initiatives, coordinate training and drive engagement of site colleagues.

Requirements:

• Associates degree with minimum experience of 5 years in Automation, Engineering, Technology or Software Programming. Prior experience programming, designing, and maintaining industrial control systems is preferred. Experience in the pharmaceutical or biopharmaceutical industry is desirable.
• Strong Allen Bradley PLC (ControlLogix, CompactLogix) and HMI/SCADA (Rockwell Automation FactoryTalk View SE, PlantPAx library version 4.0 and higher, etc.) programming skills.
• Understanding of the various Rockwell Automation FactoryTalk Suite of software applications e.g., HMI View SE, Historian SE, Directory, Services Platform, Diagnostics, Transaction Manager, etc.
• Basic understanding of software quality system principles (e.g., GAMP) and engineering documentation required for cGMP process equipment (e.g., GEPs).
• Working knowledge of database management software, security, and reports (MS-Access, SQL, SQL Audit, SSRS Reporting).
• Familiarity in Industrial Control Systems (ICS) Cyber-Security guidance, rules, and applications e.g., Claroty, Digital Immunity, Cisco Firepower, Firewall Rules, USB Kiosk Scanners, etc.
• Working knowledge of Virtual Environments (VMware), Windows Operating Systems, Security, and data storage, including, but not limited to Server 2016, Domain Controller and Policy Management.
• Highly effective written and verbal communication skills required.
• Detail orientated and self-motived candidate is a plus.
• Knowledge in Allen Bradley/Cisco network switch hardware, configuration and setup is desired.

For further information or to apply, please reach out to careers@synterex.com.

Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.