Automation Engineer

Role Summary

Automation Engineer in Swiftwater, PA responsible for supporting manufacturing system automation, implementing changes to automation systems, updating design documents, executing testing, troubleshooting, and providing site on-call support. The role provides SME-level support for automated process control systems used in licensed manufacturing and serves as the interface with Operations, QA Compliance, Information Systems, Engineering, Maintenance, and site Automation Support technicians. You will bring deep knowledge of process control systems and equipment used in biotech/pharma manufacturing and utility systems, to support complex automated systems, coordinate contractors, and contribute to process deviations investigations to improve quality and yields. The role aims to improve response times to failures and implement site automation standard procedures and Global Engineering Practices.

Responsibilities

• The Automation Engineer will oversee automation control systems within the whole site but mostly dedicated to Buildings with DeltaV system.
• 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 and 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.

Key Involvement in Decision-Making Process

• D: Decide on technical configurations, programming standards, and system integration methods
• I: Provide feedback on IoT roadmap to optimize production connectivity.
• I: Contribute to project prioritization and resource needs based on project progress.
• A: Maintain and update compliance documentation, as directed.
• A/I: Identify and support process improvements under strategic guidance.
• A/I: Assist in OT/IT integration with cybersecurity compliance to ensure secure system interoperability.

Education

• Bachelor degree in engineering, electrical, chemical, mechanical, automation, computer science, biotechnology, or applicable technical field related to engineering in the biopharma sector.
• Languages: English proficiency.

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.