Process Engineer Scientist

NOTE: Qualified candidates must be legally authorized to be employed in the United States. Union Agener does not anticipate providing sponsorship for employment visa status (e.g H-1B or TN status) for this employment position and no relocation.

Position Brand Description

The process scientist/engineer is responsible for supporting daily production, implementing process improvements, and provides technical leadership and expertise for production operations in the areas of Process and Equipment Qualification, Improving the Manufacturing and Business Processes, Process Safety Management, and Adherence to Business systems. The process scientist/engineer is considered the secondary support for the process equipment and ensures proper care and maintenance practices are being followed to maximize the equipment performance and life. Processes include of the following: Aseptic, Fermentation, Formulation, Filling, Operational Excellence, Purification, and/or Utilities.

Position Description, Functions, Duties, and Tasks:

• Ensure equipment is commissioned and qualified to meet all safety, compliance, and operational objectives.

• Provide oversite and ownership for the development of key operational procedures.

• Secondary process owner at the unit operations level, integrating process and equipment knowledge.

• Monitor established control systems for process indicators to identify and follow-up on significant issues.

• Utilize formal problem-solving techniques, including root cause analysis, to resolve issues leading to production delays.

• Own equipment-related deviation investigations, corrective/preventive actions, and changes.

• Perform equipment periodic reviews and maintain the qualified state of systems supported.

• Attend and participate in process team meetings.

• Identify new equipment/unit operations technologies.

• Technical expert/support for installation and maintenance of process equipment.

• Transfer knowledge of equipment capabilities and operational techniques to operations and maintenance.

Improving the Business or Process

• Develop/maintain project improvement activities for capacity (yield, cycle time, cleaning, etc.); product quality, raw material cost, waste loads, process variability, equipment reliability and process safety.

• Perform and summarize improvement opportunities in technical reports through statistical analysis, plant trials, investigations, and process/unit operations modeling.

• Understand process/unit capacity constraints, and identify projects to prevent conflicts.

• Develop proposals to close identified gaps for process, unit, and site metrics and other business units.

• Develop capital project business cases and act as user representative for capital projects or delivery agent for local projects.

Process Safety Management

• Provide the technical leadership and problem-solving skills for critical safety and process safety incident investigations.

• Performs compliance related technical tasks such as emissions calculations, equipment evaluation, and application of material balances for environmental needs.

Adherence to Business Systems

• Manage the implementation of countermeasures arising from deviations, spills, and safety related events.

• Analyzes process metrics including cycle time, waste, etc.

o Cycle time

o Change over time

o Waste loads

o Schedule conformance

o Process variability

o Event root causes

o Mass balance of product

• Maintain and establish the technical information for the processes.

o Equipment procedures

o Hazard information/data

o P&IDs

o Material of construction compatibility

o Process Flow Diagrams (PFDs)

o Unit operation sequence

o Material and energy balances

o Characterizing performance metrics

o Process Safety Information (PSI)

• Creation and maintenance of SOPs.

Operational Excellence

• Support the achievement of site KPIs, continuous improvement, and/or critical Safety and Quality needs using lean/OpEx principles and tools.

• Influences and supports any improvement initiative associated with the lean elements of common objectives, efficient high quality and safe work, continuous improvement, and development of people.

Minimum Qualification (Education, Experience and/or Training, Required Certifications): Education:

• Masters Degree in Engineering, Science, with 10 plus years of experience.

• Preferred Doctorate Degree in Chemical Engineering

Experience:

• Understanding of and experience with fermentation, homogenizers, chromatography, UF system, lyophilization, milling and sterile filling lines.

• Understanding of and experience with pharmaceutical cGMPs and their application to work processes.

• Understanding of and experience with automated processes. Familiarity with Distributed Control Systems (DCS) (i.e. DeltaV, PRoVOX, etc.) and/or Programmable Logic Controller (PLC) systems.

• Ability to work effectively with other plant functions, including Tech Service/Manufacturing Sciences, Automation, Maintenance and Reliability, Quality Assurance, Quality Control, Project Engineering, Validation, and Logistics.

• Expertise in root cause analysis tools (e.g. Causal Factor Charting, Fishbone Diagram, Fault Tree Analysis, Failure Mode and Effects Analysis (FMEA), etc.)

• Lean and/or Six Sigma experience.

• Strong written and oral communication skills. Ability to communicate effectively with all levels of the organization from plant management to operations specialists.

• Excellent organizational, project, and time management skills. Ability to effectively manage and prioritize competing priorities and to handle change productively.

• Advocate for training and knowledge sharing.

• Ability to develop and implement innovate problem-solving approaches.

• Strong computer skills in various software packages (MS applications, Aspen PE, etc.)

• Ability to influence others and managed difficult situations

• Competent in project planning and management

• Strong problem-solving skills and analytical skills (Root Cause Analysis)

• Strong knowledge of business processes associated with the ATC value stream

Additional Preferences:

• Self-managed and self-motivated-comfortable working in an agile environment

• Strong desire to change and improve

• Appreciated interpersonal challenges in improvement projects and change and knows how to resolve them

• Attuned to dynamics and culture of the organization.

• Ability to understand processes and own/support Project Management activities.

Other Information:

• Must be able to travel to all areas of the plant which may include walking, climbing various levels of stairs or ladders, at various floor levels in various buildings as well as the exterior of the building.