Engineer 2, Instrumentation & Controls

Merck & Co.; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Fujifilm is seeking an I&C Engineer to support instrumentation, automation, and metrology-related tasks across the campus. The role focuses on reliability, maintenance strategies, and regulatory compliance within a GMP environment.

You will work with Senior Engineers and maintenance teams to develop procedures, troubleshoot equipment, and ensure adherence to safety and regulatory standards.

Qualifications

• Bachelor’s degree in Engineering with 2 years of experience in process utility components and systems.
• Experience in GMP or other highly regulated environments.

Responsibilities

• Coordinate with Senior Utility Engineers to ensure project deliverables meet company standards.
• Assist in development of Project Change Controls (PCCs) and documentation of changes.
• Assist with deviations and change controls resolutions and closures.
• Coordinate reviews of submittals, installation, and testing of equipment across all buildings on site.
• Perform field walkdowns to ensure systems are installed per approved standards.
• Provide engineering support for plant utilities and systems (e.g., steam boilers, cooling systems, compressed air).
• Support development of SOPs and maintenance/troubleshooting procedures.
• Collaborate with operators and technicians to resolve operational issues.

Skills

Effective communication

Regulatory compliance

Problem solving

Documentation

Ability to present information

Team collaboration

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Office

SharePoint

Job description

Overview

The I&C Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with instrumentation and automation systems and controls across the campus. The I&C Engineer provides support for the metrology department through evaluations of instrument deficiencies, test equipment issues and calibration strategies and methods. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities include supporting deviation investigations and documentation for associated system deficiencies.

What You’ll Do

• Coordinates with Senior Utility Engineers within assigned discipline to ensure project deliverables (e.g., specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards
• Assists in the development of Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
• Assists with deviations and change controls resolutions and closures, as needed
• Coordinates reviews of submittals, installation, and testing of equipment within assigned discipline across all buildings on site
• Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings
• Provides standard engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)
• Partners with Senior Engineers to review and approve Preventative Maintenance templates for equipment within assigned discipline
• Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues
• Supports the development of User Requirement Specs, Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting
• Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers
• Performs standard troubleshooting for equipment challenges
• Cross-trains on multiple disciplines to assist team with achieving deliverables
• Collaborates with other departments (e.g., Utility Operations, Facilities, Environmental Health & Safety)
• Other duties, as assigned

Knowledge & Skills

• Effective communication, both written and verbal
• Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations
• Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)
• Ability to utilize software programs related to job responsibilities
• Ability to analyze and troubleshoot system and component related issues
• Ability to effectively present information to others

Required Skills

• Bachelor’s Degree in Engineering with 2 years of experience with process utility related components and systems
• Experience working in a Good Manufacturing Practices (GMP) or other highly regulated environment

Preferred Skills

Experience establishing processes and procedures for operation, troubleshooting and monitoring process utility systems.

Working Conditions & Physical Requirements

• Will work in environment which may necessitate respiratory protection No X Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
• Ability to discern audible cues. No X Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes
• Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
• Ability to stand for prolonged periods of time. No X Yes 60 minutes
• Ability to sit for prolonged periods of time. No X Yes 60 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
• Ability to operate machinery and/or power tools. No X Yes
• Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 50 lbs.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).