Process Automation Engineer

SK pharmteco Inc.; King of Prussia (Montgomery County); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled Process Automation Engineer to lead the design and optimization of automated processes in a dynamic pharmaceutical environment. This pivotal role involves ensuring compliance with safety and quality standards while enhancing production efficiency through innovative automation solutions. The successful candidate will collaborate closely with cross-functional teams to troubleshoot and improve processes, manage project scopes, and provide leadership to the automation engineering team. If you are passionate about driving process improvements and thrive in a collaborative setting, this opportunity could be the perfect fit for you.

Qualifications

• 7+ years in pharmaceutical manufacturing or technical service.
• Experience with cGMP compliance and process validations.

Responsibilities

• Ensure production, safety, and quality requirements are met.
• Design and optimize automated processes and systems.

Skills

Process Automation

Project Management

Analytical Skills

Communication Skills

Problem Solving

Education

Bachelor's degree in Engineering

Tools

Ignition SCADA

Schneider Electric building management system

Job description

Company Overview
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, The United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.

Position Summary
The Process Automation Engineer shall be responsible for ensuring that site production, safety, and quality requirements are met by establishing process control alarm ranges and sequences, and analyzing/troubleshooting system outputs and data. The process automation and controls engineering team will be responsible for designing, optimizing, and troubleshooting automated processes and systems at Levels 0, 1, and 2 onsite. Coordinating with IT Automation team for design, selection and implementation of system control platform project and improvements. These may include any or all of the following stages: scope definition, feasibility studies, pilot testing & modeling, simulation, cost/benefit analyses, design, specification development, project planning, implementation, and post-implementation monitoring and follow-up. The incumbent must be capable of managing a team of instrument, controls and automation resources, establishing process automation strategy to meet team objectives. This position will report to the Director of Engineering.

Primary Responsibilities

1. Process & Project Development

• Subject Matter Expert (SME) for process controls, instrumentation, and automation for equipment and systems at Levels 0-2. Systems include Ignition SCADA environmental monitoring system; Schneider Electric building management system.
• Identify opportunities and develop solutions for process improvements from an automation and controls perspective for implementation of new equipment, process software, building systems and monitoring or other control platforms.
• Define scope of project in consultation with supervisor and stakeholders. Individually or collaboratively through leadership of project team, define alternative solutions, and decision criteria used to evaluate the alternatives.

Equipment, Component & Process Specification

• Within projects or as part of system definition across multiple business units, designs and specifies equipment functional operating requirements. Define system design, operation, and alarm control ranges and values with input from equipment and process owner, facilities, and engineering teams.
• Define alarm criticality and system response with stakeholder input.
• Oversee configuration of systems and alarms to maintain specified process ranges and ensure proper system alarm response and recovery.
• Develop site standards and equipment and system requirements for design and implementation of automated process equipment and systems.
• Develop and oversee automated system change management processes to ensure automated equipment and systems maintain validated state, and associated documentation reflects current system operation.
• Interface with CQV team(s) to provide technical input or review and approve testing documents and protocols of automated systems as required.
• Develops control strategies for process and building platforms including operational and functional criteria for parameter setpoints and alarm ranges.
• Apply knowledge of controls standards and advanced knowledge of process controls, automation, and systems function.

Troubleshooting and Process Improvement

• Investigate, analyze, and report equipment or system outputs and data to troubleshoot quality or performance issues and optimize processes. Propose design solutions and coordinate system updates and improvements with system owner and applicable stakeholders including quality, manufacturing, and facilities.
• Leads proactive problem solving efforts for EMS/BMS controls platforms. Troubleshoots and resolves complex process controls issues and determining short- and long-term solutions.
• Develops and implements methods to systematically evaluate manufacturing process and equipment problems, analyze process data, and make recommendations to prevent recurrences.
• Works closely with cross-functional groups to identify, investigate and resolve system problems.
• Work closely with IT Automation department to integrate systems and controls into existing and planned site networks and controls infrastructure, select appropriate instruments and controls solutions, and interface with Level 3 automation systems.

Management / Strategy

• Develops detailed plans and prioritizes the tasks within process automation engineering team to achieve operational and functional goals. Cross-functional coordination with other engineering and support services teams.
• Provides leadership, oversight, instruction and development opportunities for process automation team staff. Manages process controls and automation engineering team by setting design standards and requirements, goals, and operation.
• Oversees contractor/consultant performance.

Quality Compliance

• Promotes cGMP compliance within the workplace by following site cGMP procedures. Incorporate cGMP and regulatory compliance into all assigned projects scope, design and construction work.

Education & Experience

• Bachelors degree in Engineering or another related scientific area with 7+ years experience in positions of increasing responsibility within pharmaceutical manufacturing operations or technical service.
• Experience with continuous improvement of processes and validations of processes/equipment.
• cGMP experience in a biopharmaceutical manufacturing environment.
• Self-motivated, results- and solution-oriented personality.
• Ability to combine and apply modern automation engineering and manufacturing concepts to meet complex tasks.
• Well-developed communication and interpersonal skills.
• Good organizational and project management skills.
• Highly analytical and structured way of working.
• Ability to successfully collaborate with teams across different organizational levels.
• Sound experience in Project management, task prioritization and team leadership.

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.