Automation Engineer

Role Summary

Automation Engineer role at the Swiftwater, PA site within Manufacturing Systems & Automation. You will support manufacturing system automation, implementing changes to automation systems, updating design documents, executing testing, troubleshooting events, and providing SME-level site support for automated process control systems used in licensed manufacturing. The position interfaces with Operations, QA Compliance, Information Systems, Engineering, Maintenance, and site Automation Support technicians. The role requires strong customer communication and in-depth knowledge of process control systems and equipment used in biotech/pharmaceutical manufacturing and utility systems, with hands-on support of complex automated systems to improve quality and yields.

Responsibilities

• Ensure seamless integration of automation systems with digital applications to support production, quality control, and data management.
• Ensure GMP and regulatory standards compliance (C&Q), including development of user/functional/detailed specifications, test protocols, and system validation; work with clients to tailor strategies via site assessments.
• Identify and proactively manage risks; ensure GMP compliance to minimize disruptions to timelines and costs.
• Develop and deliver specialized training materials for staff and provide ongoing post-implementation support.
• Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer to capture and document detailed requirements.
• Develop standards and best practices for development and validation; lead cross-functional teams through design reviews and user acceptance testing during the development/change and validation process.
• Participate in facility operational meetings to ensure facility reporting needs are met.
• Oversee daily monitoring, troubleshooting, and support of automation systems (PLCs, SCADA, DCS) to ensure continuous production with minimal downtime and maximum efficiency.
• Identify, propose, and implement process and system improvements to enhance automation performance, reduce costs, and improve flexibility in manufacturing operations.
• Work closely with engineering, production, quality, IT, and other cross-functional teams to ensure alignment of automation systems with production goals and regulatory requirements.
• Ensure that all automation activities comply with GMP, safety standards, and other relevant regulations; lead efforts to manage risks and address compliance issues proactively.
• Be available to provide on-call support during off-shift hours, based on a rotating schedule, to support manufacturing operations.

Qualifications

• Required: Bachelor's degree in engineering or related technical field (Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, Computer Science, and/or applicable technical field in the biopharma sector).
• Required: 2+ years of direct experience in automation systems and automation support; working in biopharma or related industries is preferred.
• Required: Knowledge of DCS (DeltaV), SCADA (Aveva), PLCs, and related automation technologies in a manufacturing context; machine connectivity and data acquisition from PLCs into higher-level applications (Historian, ERPs) using OPC.
• Preferred: Experience working in biopharma or related industries.

Skills

• Team Collaboration: Ability to collaborate effectively with cross-functional teams.
• Analytical/Problem-Solving: Strong analytical and problem-solving abilities.
• Communication: Effective communication skills for engaging diverse stakeholders across projects.
• Languages: English proficiency in written and spoken form.

Education

• Bachelor’s degree in engineering or related technical field (Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, or related biopharma disciplines).