Sr. Automation Engineer

Job Title: Sr.

Automation Engineer Job Location: Parsippany NJ 07054 Onsite Requirements: Expertise in Software Lifecycle Mgt & Documentation, Technical evaluations, and Drafting & Executing Test Plans within GxP environment; strong knowledge of GAMP 5.

Familiarity with ISA S88/S95 standards.

Degree in Engineering (Electrical, Computer Science, etc.) or related field.

8+ years of experience in designing, programming and maintenance of control systems and data acquisition systems, preferably in GxP Environment.

Job Description: Responsibilities: Responsible for interfacing with department leadership and project managers to ensure appropriate level of technical support and direction are provided.

This position will work closely with the Process Engineering, IT and validation & QA teams to set directions for standardized and optimized automation engineering practices associated with process and facilities equipment.

Responsible for providing support to Manufacturing and Packaging teams related to automation issues.

Responsible to work with Global IT / OT team in establishing harmonized OT solutions across manufacturing entities.

Responsible for the support and execution of automation qualification and applicable software validation.

Maintain the safe and qualified automation design and operation of process and facilities equipment.

Manage the design and implementation of automated systems and perform the qualification or validation steps (FAT, SAT, commissioning, IQ, OQ and PQ) according to GAMP 5.

Provide oversight on automation engineering design standards and practices.

Local project management and oversight of inter-related activities including resource planning, tasks assignment and priorities.

Establish and maintain technical standards and SOPs for automated systems and equipment (Building, Manufacturing and packaging equipment), and associated network infrastructure.

Implement updates of the systems, coordinate/perform the preventive and corrective maintenance on automated systems; update the technical and validation documentation after modifications on systems.

Provide investigational and problem-solving support to end users/shop floor, with a focus on system enhancement and sustainability to prevent future occurrence of system issues.

Assist with investigation documentation and impact assessments, assist in identification and execution corrective and preventative actions (CAPAs). Author and Update technical documentation such as Design Specifications, System Administration SOPs, System Reviews, etc.

via document control system.

Technical Requirements: Degree in Engineering (Electrical, Computer Science, etc.) or related field.

8+ years of experience in designing, programming and maintenance of control systems and data acquisition systems, preferably in GxP Environment.

In-depth knowledge and experience in the following area of responsibility: Pharmaceutical Manufacturing Process, Engineering Design, Capital Project Mgt, Project Scope Definition, Budget Preparation and Management, On-Demand Operational Support.

Expertise in Software Lifecycle Mgt & Documentation, Technical evaluations, and Drafting & Executing Test Plans within GxP environment; strong knowledge of GAMP 5.

Familiarity with ISA S88/S95 standards.

Preferred Technical Knowledge: Knowledge of SCADA, Ignition 8.1, Data Historian, OSI PI, MES, Industry 4.0, IIoT, and Smart Manufacturing technologies, Allen Bradley Control Logix, Siemens SIMATIC, Rockwell Automation (AB Control Logix), OPC/UA, MQTT, TCP/IP Protocol and standards **3rd party and subcontract staffing agencies are not eligible for partnership on this position.

3rd party subcontractors need not apply.

This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future**