Lead Controls Engineer

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 to be used in the development and manufacture of commercially viable pharmaceutical products based on additive manufacturing platforms. Assume engineering responsibility for the design, development, programming, validation, and troubleshooting of automation and process control systems utilized within Aprecia's 3DP-based (three dimensional printing) solid dosage manufacturing equipment. The position will participate with department management, Information Technology, and other appropriate internal and external contributors to develop and execute company strategy for process automation and control systems. Lead all controls aspects of the development of new (or existing) cGMP manufacturing equipment intended for production or product development. Depending on project scope, may take the role of technical project manager to develop unique solutions with external partners. Support efforts to develop overall architecture, functional requirements, design specifications, and implementation and execution for all levels of integrated automated manufacturing systems (e.g. instruments / sensors, PLCs, SCADA, MES, Historian, etc...). Generate and execute various engineering and validation documents associated with Aprecia's manufacturing equipment, ensuring that pharmaceutical products are manufactured in a cGMP manner that accounts for efficiency, safety, efficacy, and quality.

Primary Duties and Responsibilities (Essential Functions) :

Duties / Responsibilities 1 Assume SME (subject matter expert) responsibility for the control systems, PLC programming, motion controls systems, and sensing technology on Aprecia's advanced 3DP manufacturing equipment. 2 P rogram, configure, specify, and troubleshoot PLCs, HMIs, VFDs, Vision Systems, Print Systems or other instrumentation or integrated systems. Develop and integrate equipment with custom software applications across a variety of platforms and device OEMs such as B&R, Rockwell / AB, Siemens, Keyence, Cognex, etc. 3 Identify and integrate new technologies to improve the control of the manufacturing equipment in partnership with engineering colleagues. 4 Execute FMEA and safety risk assessments to determine safety requirements of automated manufacturing systems per ISO and NFPA standards. Drive controls system hardware selection and implementation to create functionally safe systems capable of achieving SIL levels dictated by assessments as confirmed by SISTEMA. 5 Support the structuring, development, integration, and maintenance of a digitally integrated manufacturing facility included but not limited to SCADA, SDMS, LIMS, MES, BAS, QMS, data historians / storage, or other digital software solutions. 6 Assist with or lead (as required) technical investigations of non-conformance or automation issues. Develop corrective and preventative actions plans to provide practical manufacturing solutions in compliance with regulatory requirements. 7 Utilize technical knowledge to identify and recommend process improvements to existing equipment and systems to improve safety, reliability, and operability. Provide engineering support pertaining to process improvements, risk analysis, and troubleshooting.

Reporting to this Position :

No direct reports

Travel :

Position may require 0-20% travel to vendors, strategic partner sites, and customer sites

Work Shift :

Position typically works days but occasional support may be needed at other times

Knowledge, Skills and Abilities :

• Excellent oral and written communication skills
• Excellent data organization and presentation skills
• Strong problem-solving and critical thinking skills
• Ability to operate successfully in a team environment
• Strong automation and process background
• Strong interpersonal and influencing skills to participate and / or lead (as needed) cross-functional teams, successfully challenging them to work collaboratively on engineering solutions and meet project deadlines
• Willingness to work extended hours when required to complete projects on time
• Understanding of cGMP (current Good Manufacturing Practices) preferred

Education and Experience :

Physical Demands and Work Environment :

GENERAL INFORMATION :

The expectation for all employees is to support the company's mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.