Sr. Mfg. Engineer I

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Job Description

We are seeking a highly motivated Senior Automation Engineer to join our Automation Department in support of the operation of our state-of-the-art facility, home to several new sterile manufacturing lines, packaging lines, and product warehouse. In support of our new facility, the Senior Manufacturing Automation Engineer I, under minimal supervision, will be responsible for managing the Automation team in continual infrastructure and control system enhancements, administration and maintenance of physical and virtual servers and automation layer networks, and manufacturing operational support related to supervisory level automation systems. In maintaining these systems, the individual will be responsible for ensuring that all systems are in keeping with the site standards for Automation, including virtualization, IOT/IIOT frameworks, centralized supervisory software, as well as the data integrity and compliance guidelines required of GMP systems.

The automation systems which the individual will be responsible for includes the Process Control System (PCS) and PCS Information Management System (PIMS), which contains FactoryTalk View, FactoryTalk Historian (OSI PI Historian), FactoryTalk Transaction Manager and SQL Reporting, FactoryTalk AssetCentre, Automation Active Directory servers, Remote Desktop Terminal Servers, and more. The PCS also includes interfacing to IT infrastructure and firewalls, and multiple site-wide fiber networks to ensure secure, highly available network communications between the manufacturing equipment and PIMS. As such, this individual will work closely with IT and manufacturing while collaborating with the site's Quality Assurance, Validation, Engineering, Facilities, and other stakeholders.

Additionally, as all systems are interfacing to the GMP network, the individual should be well versed in FDA Code of Federal Regulations Title 21, Part 11, Computer Systems Validation, GAMP, Data Integrity Compliance, and GMP change management procedures. The individual will be expected to use Maximo, TrackWise, and Veeva Vault systems to facilitate development of documentation, standard operating procedures, work orders, and change management records in line with automation system maintenance and enhancements.

Extensive knowledge of control layer hardware and programming (Allen Bradley ControlLogix, Studio 5000) is strongly preferred, but may supplement roles and responsibilities related to the supervisory level software and hardware.

Responsibilities of the Senior Automation Engineer include:

• Administration and maintenance of the automation servers, systems and network devices for process equipment and systems, with key emphasis on data integrity, high reliability, and redundancy.
• Supervising and onboarding automation contractors in support of project implementation and operational troubleshooting.
• Supporting manufacturing operations in areas related to the automation infrastructure and networks, including cross-functional communication and coordination to resolve issues, and providing automation technical expertise for troubleshooting, investigations and training.
• Operational Projects: Developing, planning and implementing automation-based projects and solutions in collaboration with cross-functional teams, including determination and delivery on cost, time and quality to ensure the sustained production (these projects may be new and/or update to existing).
• Optimization and compliance: Responsible for technical optimization of the automation systems, including the revision of automation standards in keeping with current Good Manufacturing Practices and new industry technology and best practices.
• Creation, modification, and maintenance of automation documentation, including automation specification documents (URS, FDS, SDS), SOPs, P&ID, network topology, PFD, wiring diagrams, panel drawings, etc. in a compliant state.
• Leading a team in the development of commissioning protocols and commissioning reports following project implementation .
• Support the validation of automation systems with Validation department and provide technical skills in regards to Computer Systems Validation strategies.
• May participate in audits to include internal, vendors or contract manufacturers.
• Supports and contributes to site continuous improvement initiatives, including compilation of key performance indicators and technical performance metrics.

Knowledge & Skills

• Demonstrates extensive understanding and application of process engineering principles, concepts, practices, and standards.
• Demonstrates proficiency in current Good Manufacturing Practices (GMPs), 21 CFR Part 11/Annex 11, regulatory compliance, strategic planning, data management, and safety regulations.
• Demonstrates knowledge of pharmaceutical process manufacturing, OEE, MTBF, and root cause failure analysis.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Proficient in Microsoft Office applications

Basic Qualifications

• A minimum of eight (8) years of relevant experience, and a BS or BA or related fields.
• A minimum of five (5) years of relevant experience, and a MA or MBA.

Preferred Qualifications

• Has experience with automated infrastructure that include: security strategies, network architecture, platform selection and full implementation of 21 CFR Part 11 and EU annex 11 requirements
• Has experience with Rockwell Software suite: FactoryTalk View, FactoryTalk Historian (OSI PI Historian), FactoryTalk Transaction Manager, FactoryTalk AssetCentre
• Has experience with SQL Database and Reporting
• Has extensive experience in PLC and HMI Allen Bradley hardware programming (ControlLogix, PanelViews)
• Has previous experience in biotech or pharmaceuticals industry.
• Has previous experience in engineering in highly-regulated manufacturing environments.

The salary range for this position is: $117,725.00 - $152,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.