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.

No direct reports

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

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

• 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…