Automation Engineer

About the role

As an Automation Engineer, you will serve as the technical owner for process and utility systems, ensuring reliable and effective automation throughout operations. You will partner with Process Engineering to support equipment qualification, ongoing operations, deviation resolution, maintenance activities, and system decommissioning, helping to drive process performance, compliance, and continuous improvement.

Responsibilities

• Create engineering deliverables including P&IDs, Instrument Data Sheets, Functional Specifications, Panel Drawings, Network Architectures, Standard Operating Procedures, etc.
• Implement system modifications under cGMP change control.
• Develop and execute Factory Acceptance Tests (FAT), commissioning protocols, and qualification protocols.
• Support software lifecycle, electronic batch records, and electronic signature compliance efforts.
• Participate in investigations into system deviations and implement corrective actions and preventative actions.
• Develop, evaluate, and implement engineering solutions to complex problems.
• Stay current with automation and IT best practices and technologies as related to site activities.
• May serve as project manager on small sized projects.
• Assist lead engineers in development and implementation of programs related to system qualification, asset management, project execution, and GEPs.
• Interface with various roles and departments to accomplish project goals.
• Work under supervision and have the ability to plan, prioritize work, and know when to escalate issues.
• Complete mandatory training within required timeframe.
• Perform other duties as assigned.

Requirements

• Bachelor of Science degree in Engineering or related field.
• Preferred education is Bachelor in Chemical Engineering or Electrical Engineering.
• 1-5 years as an engineer with process automation focus preferred.
• Experience working in FDA regulated industry utilizing cGMP preferred.
• Familiarity with PLC programming and SCADA configuration.
• Familiarity with Batch-based control systems and Data Historian systems, SQL databases, Scripting languages (VB, etc.) preferred.
• Familiarity with a variety of instrumentation and sensing technologies related to pharmaceutical manufacturing.
• Demonstrated track record of successfully participating in implementation of control system components and strategies.
• Hands-on experience with the operation, support, or design of the following systems: bioreactors, centrifugation, chromatography, tangential flow filtration, Clean-in-Place systems, autoclaves, or clean utility systems preferred.
• Knowledge of Process Engineering and Electrical Engineering Concepts, like fluid dynamics, thermodynamics, and power systems a plus.
• Proficient computer skills and experience using MS Office software (Word, Excel, and PowerPoint) and MS Project.
• Knowledge of IT practices with respect to Windows Operating Systems and Networking a plus.
• Embrace working in a fast-paced, team-oriented, cross-functional environment.

Important Considerations

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
• In general, the position requires a combination of sedentary work and walking throughout the facility.
• May occasionally climb ladders.
• May be required to lift up to 25 lbs.
• Requires participation in 24/7 on-call support rotation with other automation and process engineering personnel.
• Infrequent travel but may approach 25% during project activities.

Pay

U.S. Base Salary Range: $71,800.00 - $112,860.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Benefits

• Short-term and/or long-term incentives.
• Medical, dental, and vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires are eligible to accrue up to 120 hours of paid vacation.