Manufacturing Process Control Engineer (pharma)

Job Title: Technical Lead/Admin – Process Control Systems

Location: Foster City, Onsite (5 days a week)

Duration: Long Term Contract

Job Summary:

We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates, administering system security, resolving technical issues, and ensuring system reliability under the direction of a System Manager.

Key Responsibilities:

• Perform periodic system maintenance activities such as System Maintenance, Server Maintenance, System Audit Trail Review, User access reviews and coordinating with IT and drive completion of server maintenance.
• Monitor system performance, identifying bottlenecks and working with system manager to implement solutions to optimize system UI/UX. Perform periodic system health checks.
• Validate compatibility of OS patches with the application and co-ordinate with IT for installation of patches and perform post-patch verification testing on a periodic basis.
• Work with the System Manager to evaluate application patches on a periodic basis, perform installation of approved patches and assist Validation Engineers in regression testing following patch installation.
• Administering system security and access control such as creating, managing and updating user accounts within the system environments per applicable procedures.
• Collaborating with the System Manager to create and maintain training content and provide training to users requesting access.
• Troubleshoot and resolve hardware, software issues and collaborate with IT to resolve network-related issues impacting system availability and performance.
• Provide technical support during change management and assist automation engineers and/or system integrators in deploying changes to systems.
• Provide technical support for validation engineers performing annual backup and restore testing as well as disaster recovery testing.
• Assist validation engineers in installation, operational and performance testing as well as perform IQ/OQ/PQ testing, when required.

Qualifications and Skills:

• Bachelor's degree in computer science, Engineering, Industrial Automation, Information Technology, or a related field (or equivalent experience).
• Minimum of 3-5 years of experience administering or integrating process control systems, specifically. Rockwell FactoryTalk-based systems and/or Inductive Automation's Ignition based systems. Experience interfacing with PLCs, SCADA, or historian systems.
• Excellent communication skills and the ability to work collaboratively with technical and non-technical teams.
• Experience deploying and configuring systems in a production environment. Strong troubleshooting skills with the ability to diagnose and resolve complex technical issues efficiently.
• Demonstrated experience working in a GMP-regulated environment with a thorough understanding of FDA regulations (e.g., 21 CFR Part 11).
• Familiarity with system validation, change control, and documentation practices in a regulated setting.
• Experience in authoring and executing change control for implemented GMP systems.
• Ability to prioritize tasks and manage multiple responsibilities in a fast-paced environment.
• Keen attention to detail and a commitment to maintaining compliance with regulatory standards.

Preferred Skills:

• Relevant certifications (e.g., Rockwell Automation, Ignition, or similar) are highly desirable.
• Proficiency in operating system administration (windows and Linux), network administration, Python scripting, or automation is a plus.

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. 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.