Lead Controls Engineer

Aprecia Pharmaceuticals, LLC; Mason (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative pharmaceutical company is seeking a skilled automation engineer to join their dynamic team. This role involves designing and programming advanced automation systems for 3D printing technologies, ensuring compliance with cGMP standards. You will collaborate with cross-functional teams to enhance manufacturing processes and lead initiatives for process improvement. If you have a strong background in PLC programming, automation, and process control, this is an exciting opportunity to contribute to cutting-edge pharmaceutical innovations while supporting a mission-driven organization.

Qualifications

• 5-10 years of PLC programming experience with structured text and ladder logic.
• Experience in automation within a pharmaceutical environment is preferred.
• Hands-on troubleshooting experience is required.

Responsibilities

• Lead programming and integration of PLCs and automation systems.
• Conduct FMEA and safety risk assessments to ensure compliance.
• Support development of digital manufacturing systems like SCADA and LIMS.

Skills

PLC Programming

Automation and Process Control

Problem-Solving

Communication Skills

Teamwork

cGMP Practices

Education

B.S. in Chemical Engineering

B.S. in Mechanical Engineering

B.S. in Electrical Engineering

B.S. in Computer Science

Tools

B&R Controls

SCADA

LIMS

MES

QMS

MS Office

Job description

General Purpose of Position

Fill a key role on a team of engineers and scientists tasked with the innovation and development of proprietary and non-proprietary processes and process technologies for pharmaceutical products based on additive manufacturing platforms. Responsible for design, development, programming, validation, and troubleshooting of automation and process control systems in Aprecia’s 3DP-based manufacturing equipment. Collaborate with management, IT, and external partners to develop and execute strategies for process automation and control systems. Lead controls development for new or existing cGMP manufacturing equipment, and support architecture, design, and implementation of integrated automated manufacturing systems. Ensure manufacturing complies with cGMP standards, focusing on efficiency, safety, and quality.

Primary Duties and Responsibilities (Essential Functions)

1. Subject Matter Expert: Take responsibility for control systems, PLC programming, motion controls, and sensing technology on advanced 3DP manufacturing equipment.
2. System Programming and Integration: Program, configure, troubleshoot PLCs, HMIs, VFDs, Vision Systems, Print Systems, and other instrumentation. Develop and integrate software across various platforms and OEMs.
3. Technology Integration: Identify and implement new technologies to enhance manufacturing control in partnership with engineering colleagues.
4. Safety and Risk Assessment: Conduct FMEA and safety risk assessments, select hardware, and implement controls to meet SIL levels as confirmed by SISTEMA.
5. Digital Manufacturing Support: Support development and maintenance of digital systems like SCADA, LIMS, MES, QMS, and data historians.
6. Issue Resolution: Lead investigations into non-conformance or automation issues, and develop corrective actions for regulatory compliance.
7. Process Improvement: Use technical knowledge to recommend and support process improvements for safety, reliability, and operability.

Reporting and Work Environment

No direct reports. Travel may be required up to 20%. Typically works days with occasional support outside regular hours.

Knowledge, Skills, and Abilities

• Excellent communication, data organization, and presentation skills
• Strong problem-solving and teamwork skills
• Background in automation and process control
• Interpersonal skills to lead cross-functional teams
• Willingness to work extended hours as needed
• Understanding of cGMP practices (preferred)

Education and Experience

• B.S. in Chemical, Mechanical, Electrical Engineering or Computer Science
• 5-10 years programming PLCs with structured text and ladder logic
• Experience with B&R controls and motion systems highly desired
• Automation experience in a pharmaceutical or similar environment preferred
• Knowledge of data exchange protocols and HMI development
• Understanding of validation lifecycle and electrical standards
• Hands-on troubleshooting experience required
• Proficiency in MS Office
• Experience with 3D printing technologies and electrical design beneficial

Physical Demands and Work Environment

• Sitting for extended periods, manual dexterity, minimal lifting
• Good eyesight and critical thinking skills

General Information

Support company mission and values. Duties may vary and be updated as needed. Equal opportunity employer.