Job Title: Automation Engineer

Location: Swiftwater, PA

In this role, you'll join the Manufacturing Systems & Automation department at our Swiftwater site, supporting directly the manufacturing system automation. The role will support implementation of changes to the automation systems, updating design documents, executing testing, troubleshooting events, and being a part of the site automation on-call support. The role will provide Subject Matter Expert (SME) level support of all automated process control systems used in licensed manufacturing (including dedicated clean utilities) of the building that the Automation Engineer has been assigned to. The position will be the Manufacturing Systems & Automation Site Support interface with Operations personnel, QA Compliance, Information Systems, Engineering, Maintenance and the site wide Automation Support technicians.

The Automation Engineer must exhibit strong customer communication skills and have in-depth technical knowledge of process control systems and equipment used in biotech/ pharmaceutical manufacturing and utility systems. This position will support the highly complex automated systems installed in the new and existing manufacturing facilities, security and its support systems.

Expected results from this position would include hands-on support of automated system in manufacturing (including Building Automation Systems), troubleshooting of automated process equipment and process systems, coordination of contractors, execution of site change controls, aiding in the investigation of process deviations and providing expertise for process evaluation and product improvements for better quality and yields. The role will provide improved response time to failures in manufacturing and implement site automation standard procedures and Global Engineering Practices.

Main Responsibilities:

The Automation Engineer will oversee manufacturing execution system and automation within the whole site. Key responsibilities include :

System Integration:

• Ensure seamless integration of automation systems with digital applications to support production, quality control, and data management.

Deliverable Accountability:

• Ensure compliance with GMP and regulatory standards (C&Q), including user/functional/detailed specification development, test protocols, and system validation.
• Work closely with the client to understand their needs and develop strategies tailored to their organization through site assessments.

Risk and Compliance Management:

• Identify and proactively manage risks.
• Ensure compliance with GMP to minimize disruptions to timelines and costs.

Training and Support:

• Develop and deliver specialized training materials for staff to ensure proper operation and maintenance of automated systems.
• Provide ongoing support post-implementation.

Collaboration and Documentation:

• Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer departments to capture and document detailed requirements.

Standards and Best Practices:

• Develop standards and best practices for development and validation activities.
• Lead cross-functional teams through design reviews and user acceptance testing during the development change and validation process.

Operational Meetings:

• Participate in facility operational meetings to ensure facility reporting needs are met.

Operational Oversight:

• Oversee the daily monitoring, troubleshooting, and support of automation systems (PLCs, SCADA, DCS, and other control systems) to ensure continuous production with minimal downtime and maximum efficiency.

Continuous Improvement:

• Identify, propose, and implement process and system improvements to enhance automation performance, reduce costs, and improve flexibility in manufacturing operations.

Cross-Functional Collaboration:

• Work closely with engineering, production, quality, IT, and other cross-functional teams to ensure alignment of automation systems with production goals and regulatory requirements.

Compliance & Risk Management:

• Ensure that all automation activities comply with GMP, safety standards, and other relevant regulations. Lead efforts to manage risks associated with automation systems and address any compliance issues proactively.

On-Call Support:

• Be available to provide "on call" support during off-shift hours, based on a rotating schedule, to support manufacturing operations.

About You

Education:

• Bachelor's degree in engineering, Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, Computer Sciences, and/or applicable technical field related to engineering in the biopharma sector.

Experience:

• Automation and Engineering: 2+ years of direct experience in automation systems and automation support. Working in biopharma or related industries are preferred.
• Process Control Systems: Knowledge in systems like DCS (DeltaV), SCADA (Aveva), PLCs, and/or related automation technologies in a manufacturing context. Machine connectivity understanding with data acquisition from PLCs into higher level applications like Historian, ERPs, etc. using current technologies like OPC.

Soft and Technical Skills:

• Team Collaboration: Ability to collaborate effectively with cross-functional teams.
• Analytical Skills: Problem-solving abilities.
• Communication: Effective communication skills for engaging diverse stakeholders across projects.

Languages:

• English: Proficiency in both written and spoken English.

The salary range for this position is:
$75,000.00 - $108,333.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.