Senior Engineer II, Automation & Controls

About the role

Support automation projects and automation vendors to deliver new systems, change existing systems, or retire existing systems to support business objectives.

Lead development of specifications for equipment control systems for new projects.

Lead development of specifications for building management systems for new manufacturing areas.

Review documentation for accuracy and relevance as it pertains to system controls.

Support Maintenace Department in keeping current automation and control systems updated.

Collaborate with Corporate IT in support of projects requiring interfacing.

Support network maintenance and projects owned by GAC/IT.

Communicate and coordinate all network or system interruptions with system users.

Support the computer system validation (CSV) activities for all cGMP automation equipment, including development of documentation as per the ISPE GAMP5 guidelines.

Follow standard operating procedures (SOPs) related to equipment, systems, and documentation as required.

Complete all assigned tasks following cGMPs, OSHA, EPA, and other Federal and State regulations.

Contribute to changes of all automation Standard Operating Procedures (SOP)s and system drawings.

Perform system administrator functions for some systems, including managing system users.

Perform annual system review for all automation systems.

Provide technical support during Non-Conformance (NC’s) and Corrective Action Preventive Actions (CAPA) investigations.

Perform automation code updates associated with projects.

Maintain system inventory information and backups of all validated software.

Responsibilities

• Support automation projects and automation vendors to deliver new systems, change existing systems, or retire existing systems to support business objectives.
• Lead development of specifications for equipment control systems for new projects.
• Lead development of specifications for building management systems for new manufacturing areas.
• Review documentation for accuracy and relevance as it pertains to system controls.
• Support Maintenace Department in keeping current automation and control systems updated.
• Collaborate with Corporate IT in support of projects requiring interfacing.
• Support network maintenance and projects owned by GAC/IT.
• Communicate and coordinate all network or system interruptions with system users.
• Support the computer system validation (CSV) activities for all cGMP automation equipment, including development of documentation as per the ISPE GAMP5 guidelines.
• Follow standard operating procedures (SOPs) related to equipment, systems, and documentation as required.
• Complete all assigned tasks following cGMPs, OSHA, EPA, and other Federal and State regulations.
• Contribute to changes of all automation Standard Operating Procedures (SOP)s and system drawings.
• Perform system administrator functions for some systems, including managing system users.
• Perform annual system review for all automation systems.
• Provide technical support during Non-Conformance (NC’s) and Corrective Action Preventive Actions (CAPA) investigations.
• Perform automation code updates associated with projects.
• Maintain system inventory information and backups of all validated software.

Requirements

Must work with outside equipment suppliers and internal stakeholders to develop equipment requirements and design specifications.

Qualifications

• Bachelor’s Degree in electronics, Electrical Engineering, or other related technical field with 10+ years of experience supporting automation/control or computer systems in a GMP production facility, preferably in the medical device or pharmaceutical industries
• or MS Degree with 5+ years of experience.
• Ability to take direction and work in a fast-paced environment, communicating and raising questions as needed.
• Thorough understanding of electricity, electrical circuits, analog and digital input/output devices.
• Proficiency in review of electrical diagrams and piping and instrumentation diagrams (P&IDs).
• Knowledge of Allen Bradley/Rockwell programing software (RSLogix, RSLinks, FactoryTalk, and ControlLogix) preferred.
• Knowledge of Siemens and Beckoff TwinCat programing software a plus.
• Extensive knowledge of computer networks, including switches, and firewalls.
• Understanding of cGMP, cGDP, and computer system Validation (CSV).
• Experience with noncontact measuring systems (laser, optical, ultrasonic) a plus.
• Working knowledge of ISPE GAMP5 guidelines.
• Working knowledge of Lock out Tag out (LOTO) procedures and electrical safety.
• A record of safe operations and working knowledge of safety standards for plant environments.
• Knowledge of Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA).
• Strong writing and communication skills.
• Proficiency with personal computers (Windows) and software like MS Project, Word, Excel.
• Must be available during scheduled shutdowns, in emergency situations, and / or work flexible hours.
• Available to travel on a minimal basis for training or other purposes.

Skills

• Allen Bradley/Rockwell programing software (RSLogix, RSLinks, FactoryTalk, and ControlLogix)
• Siemens and Beckoff TwinCat programing software
• Noncontact measuring systems (laser, optical, ultrasonic)
• ISPE GAMP5 guidelines
• Lock out Tag out (LOTO) procedures and electrical safety
• Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA)

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Pay

Pay Range: $94,300.00 - $129,950.00 USD