Process Automation Engineer

X4 Engineering; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

X4 Engineering is seeking a Process Automation Engineer to join its technical team serving Central and Eastern North Carolina. The role blends hands-on automation troubleshooting with commissioning, qualification, validation and change-control activities for manufacturing environments.

You will work with Manufacturing, Engineering, Validation and Quality teams, supporting automation modifications, new equipment, and documenting validation plans and test cases, all within GMP-compliant processes.

Qualifications

• Bachelor's degree in Engineering, Manufacturing Technology or related field.
• 3+ years of experience in pharmaceutical automation or a closely related regulated manufacturing environment.
• CAPM or PMP certification is beneficial; candidates who are eligible to obtain the required certification may be considered with an agreed development period.

Responsibilities

• Provide automation troubleshooting support for new and existing manufacturing systems during qualification and routine production.
• Design, implement and support automation modifications, program changes and system enhancements.
• Support installation and implementation of new manufacturing equipment from design requirements through commissioning and qualification.
• Review equipment and process documentation to identify critical spare parts and support the development or improvement of preventive maintenance procedures.
• Review instrumentation and determine calibration requirements, including supporting the development or revision of calibration procedures.
• Work with client stakeholders to define system requirements and develop documents such as User Requirements, Design Specifications and Functional Specifications.
• Prepare lifecycle and validation documentation, including risk assessments, validation plans, equipment classification and alarm assessments.
• Translate system requirements and vendor documentation into practical test cases and qualification activities.
• Develop and execute commissioning and qualification protocols, engineering studies and associated final reports or approval packages.
• Support deviation, failure and troubleshooting investigations and document findings.
• Initiate and manage change controls through the client's quality system.
• Provide project planning, coordination, execution and follow-up in collaboration with client teams.
• Create or support production documentation, including batch records, standard operating procedures and equipment-related documentation.
• Support continuous improvement initiatives relating to equipment reliability, automation performance and process functionality.

Skills

Troubleshooting

Communication skills

Team collaboration

Independent work

Education

Bachelor's degree in Engineering, Manufacturing Technology or related discipline

Tools

Allen-Bradley Studio 5000

FactoryTalk View

FactoryTalk Batch

Job description

An established engineering and manufacturing services organization is expanding its technical team across Central and Eastern North Carolina, supporting projects within highly regulated manufacturing environments. The business provides engineering, automation, integration, reliability, commissioning and qualification support to clients in industries including pharmaceutical and food manufacturing.

The Role

We are seeking a Process Automation Engineer who can combine hands-on automation troubleshooting with commissioning, qualification, validation and change-control activities. This is a client-facing position supporting manufacturing equipment, utilities, facilities and process systems from initial implementation through routine production support.

The successful candidate will work closely with Manufacturing, Engineering, Validation and Quality teams. Responsibilities will include troubleshooting existing systems, implementing automation modifications, supporting new equipment installations, developing technical and validation documentation, executing qualification activities and maintaining GMP compliance.

Key Responsibilities

• Provide automation and maintenance troubleshooting support for new and existing manufacturing systems during qualification and routine production.
• Design, implement and support automation modifications, program changes and system enhancements.
• Support installation and implementation of new manufacturing equipment from design requirements through commissioning and qualification.
• Review equipment and process documentation to identify critical spare parts and support the development or improvement of preventive maintenance procedures.
• Review instrumentation and determine calibration requirements, including supporting the development or revision of calibration procedures.
• Work with client stakeholders to define system requirements and develop documents such as User Requirements, Design Specifications and Functional Specifications.
• Prepare lifecycle and validation documentation, including risk assessments, validation plans, equipment classification and alarm assessments.
• Translate system requirements and vendor documentation into practical test cases and qualification activities.
• Develop and execute commissioning and qualification protocols, engineering studies and associated final reports or approval packages.
• Support deviation, failure and troubleshooting investigations and document findings.
• Initiate and manage change controls through the client's quality system.
• Provide project planning, coordination, execution and follow-up in collaboration with client teams.
• Create or support production documentation, including batch records, standard operating procedures and equipment-related documentation.
• Support continuous improvement initiatives relating to equipment reliability, automation performance and process functionality.

Technical Environment & Compliance

• Pharmaceutical / regulated manufacturing environments, with sterile manufacturing or medical-device experience beneficial.
• Allen-Bradley PLC platforms, particularly Studio 5000, FactoryTalk View and FactoryTalk Batch.
• GMP, GAMP and FDA / 21 CFR Part 11 requirements as they relate to automated systems and qualification.
• Manufacturing equipment, process systems, utilities, facilities and computerized systems.
• Mechanical, electrical and P&ID drawings.
• Commissioning, qualification, validation and lifecycle documentation.

Required Background

• Bachelor's degree in Engineering, Manufacturing Technology or a related technical discipline.
• 3+ years of experience in pharmaceutical automation, validation or a closely related regulated manufacturing environment.
• Strong mechanical aptitude with hands-on troubleshooting and problem-solving capability.
• Practical experience supporting automation systems in a manufacturing environment.
• Ability to work independently with limited supervision while also contributing effectively within multidisciplinary project teams.
• Strong written and verbal communication skills, including the ability to work with stakeholders at different levels of an organization.
• CAPM or PMP certification is beneficial; candidates who are eligible to obtain the required certification may be considered with an agreed development period.

Additional Information

• Primarily Monday-Friday, day-shift work.
• Role is onsite at client facilities and/or the engineering office.
• Flexibility is required to support manufacturing schedules during equipment installations, commissioning, qualification and troubleshooting.
• Occasional night, weekend or on-call support may be required depending on project and production needs.
• Standard work week is approximately 37.5 hours.
• Candidates must have current authorization to work in the United States without employer sponsorship. H-1B sponsorship and H-1B transfers are not available for this position. Candidates currently authorized to work in the U.S. through TN status may be considered, subject to role and eligibility requirements.