Process Engineer

Lewes, DE

Summary

The Process Engineer is responsible for optimizing process yields and generating projects to reduce the cost for manufacturing products. The Process Engineer regularly monitors and checks the process to assure it is operating within the appropriate parameters. The position is responsible for installing small to medium size capital projects in order to improve plantperformance, comply with Environmental regulations, and increase the Safety of the plant. The position generates IQ/OQ and Process Validation as needed per pharmaceutical regulations for these modifications. The position will also generate and implement process validations (and revalidations) for existing processes in the plant. The Process Engineer writes control code for the process PLCs and makes changes to the HMI screens, as required on a small scale, as well as coordinates the work of Control Integrators on a large scale. The Process Engineer provides technical support for the Maintenance Department as needed.

 

Essential Duties and Responsibilities

  • Observes and take measurements directly on the process, as well as collect and interpret
  • existing data from other sources, such as data historian, batch records, equipment logs,
  • and technical and operating staff involved.
  • Designs, installs, and commissions new process equipment, monitors modifications and
  • upgrades, and troubleshoots existing processes.
  • Assists with conceptual and detailed design of new equipment or processes as
  • Works with maintenance to design, spec, order, and install equipment.
  • Prepares reports, flow diagrams and charts as necessary to justify process improvements.
  • Monitors and improves the quality, cost efficiency, yield output and safety of the plant
  • Generates cost savings opportunities through engineering improvements to processes,
  • utilities, etc.
  • Assesses environmental impact of operations within the plant.
  • Manages the cost and time constraints of projects.
  • Selects, manages, and works with contractors.
  • Participates in risk assessments, including hazard and operability (HAZOP) studies, for
  • the health and safety of both company staff and the wider community.
  • Regularly reviews key process parameters.
  • Updates and writes SOP’s, checklists, etc. for new equipment or modifications to
  • existing equipment and trains employees as necessary;
  • Assists with preparing and completing process validation protocols and reports. Assists
  • site personnel in the investigation of validation deviations.
  • Prepares and executes IQ/OQ protocols for new and existing equipment.
  • Assists in troubleshooting process problems.
  • Creates, reviews and approves change in control documents for new or modified
  • equipment, SOP’s, reports, etc.
  • Provides support to the Regulatory department for various filings.
  • Implements small control system projects and gains basic knowledge of control systems
  • to troubleshoot small equipment problems.
  • Assists with process troubleshooting for toll manufacturers as needed.
  • Investigates and troubleshoots plant/process problems.
  • Ensures that equipment works to its specification and to appropriate capacities.
  • Liaises with installation/project engineers and specialists.
  • Ensures safe working conditions and compliance with health and safety legislation.
  • Develops best practices and innovative solutions to improve production rates and quality
  • of output.
  • Performs various evaluations and calculations, e.g. sizing equipment, mass and energy
  • balances, and fluid flows.
  • Determines needed improvements to the plant by running trials and interpreting results.
  • The position will periodically be needed to work off-hours in order to support installation
  • of projects, run process tests, or troubleshoot process problems.
  • Occasional call-in support during off-hours is required to help resolve process issues.
  • Other duties as assigned.

 

Education, Skills and Experience

  • Bachelor of Science degree in Chemical Engineering
  • Work experience within the pharmaceutical, food, or chemical industry in a process
  • support role is a plus
  • Microsoft Word, Excel, PowerPoint
  • Spreadsheet data entry
  • Data manipulation / statistics
  • General mathematical engineering calculation skills
  • Knowledge of controls software a plus
  • Good verbal and written communication skills
  • Good organizational and planning skills
  • Able to lead and work in a team environment
  • Possess the ability for creative problem solving
  • Ability to manage multiple priorities/project
  • Ability to collect and interpret data