My client, a growing organisation in the pharmaceutical and biotech space are recruiting an experienced Senior Automation Controls Engineer who will be responsible for the installation, upkeep, and resolution of issues pertaining to automation systems for the automated utility, processing, filling, inspection, and packaging equipment. These systems are predominantly PLC, SCADA, and PC based.

Location: Onsite in Lakewood, NJ

Key Responsibilities:

• Oversee system administration tasks including access control, software revision control, and backup/recovery operations.
• Review functional specifications for hardware and software concerning new automated utility, process, filling, packaging, and inspection equipment.
• Proficiency in interpreting electrical control system diagrams, including control panel wiring diagrams, loop drawings, and panel layout drawings.
• Execute IQ/OQ/PQ procedures post-installation, ensuring compliance with site protocols.
• Familiarity with relevant regulatory directives governing computer/automation-based systems.
• Develop user requirement specifications for control systems and define vendor design documentation requirements (21 CFR Part 11, cGMP).
• Assess and evaluate vendor automation design documentation, including FRS, DDS, and requirements traceability matrices.
• Offer technical support for the engineering and design phases of automated systems.
• Assist in the review and execution of qualification protocols for automated systems.
• Proficient in deciphering complex ladder logic and troubleshooting low voltage control wiring.
• Conduct risk assessments and manage Change Controls associated with control system modifications.
• Potential supervision of junior engineers, alongside coordination with process mechanical staff, electrical and automation contractors, and maintenance personnel.

Additional Responsibilities:

• Undertake control panel drawing reviews and maintain familiarity with PLC-based controllers and functionality.
• Collaborate with stakeholders to ensure seamless integration of vision systems, software development, and testing/validation processes.
• Demonstrate expertise in medical device and/or pharmaceutical production environments, adhering to cGMP/FDA regulations.
• Competent in configuring Excel spreadsheets and conducting automated calculations.
• Stay informed about industry best practices and guidelines outlined by regulatory bodies such as FDA, ISO, EU, and ICH.
• Possess experience with leading component vendors including Keyence, Cognex, and Seidenador, as well as major PLC vendors like Allen Bradley, Beckman, and Siemens.

Qualifications:

• Bachelor’s Degree in Electrical Engineering, Computer Science, or a related field.
• 5 years of experience in vision systems, software development, integration, testing, and validation within automated manufacturing settings.
• Prior involvement in medical device and/or pharmaceutical production, with a strong grasp of cGMP/FDA requirements.
• Proficiency in Excel spreadsheet operations and automated calculations.
• Familiarity with industry standards and guidelines prescribed by regulatory agencies.
• Extensive experience with major component and PLC vendors.
• Please note that this rewrite maintains the core elements of the original job description while offering a fresh perspective through rephrasing and restructuring.